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Table of contents :
Introduction Universal Pedicular Screw System 2
Product feature 3-4
Indications & Contraindications 5
Ordering information Implants 14-48
Mono-Axial Screws (Reduction) 14-15
Mono-Axial Screws (non-Reduction) 16-17
Poly-Axial Screws (Reduction) 18-19
Poly-Axial Screws (non-Reduction) 20-21
Set screw & Crosslinks 22
Dynamic Poly-Axial Screws (Reduction) 23-24
Dynamic Poly-Axial Screws (non-Reduction) 25-26
Rods 27-28
Hooks 29-32
Instruments 33-44
Containers & Trays 45-48
Surgical Technique Surgical Technique 6 - 13
Step 1 : Creating a screws hole 6
Step 2 : Radiographic control 7
Step 3 : Tapping 7
Step 4 : Screws insertion 8
Step 5 : Bending and attaching the rods 8
Step 6 : Rod placement 9
Step 7 : Insert the set screws 10
Step 8 : Insert the set screws(2) 11
Step 9 : Distraction / Compression 12
Step 10 : Tightening of the set screws 13
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Introduction :
Key Features & Bene ts :
Universal Pedicular Screw SystemScrew,hooks,rods and clamps
Highly versatile- Pre-bent rods
- Optimal selection of implants
- Easy-to-use instrumentation
Best performance
- Cap thread designed to reduce cross threading
- Visual and tactile indicators to ensure proper implant and instrument assembly
- Buttress Thread enhances optimal bone purchase
Easy to use
- Standard Instruments
- Snap-on,telescoping transverse connectors provides easy attachment
Please refer to the package insert for a complete list of indications, contraindications, precautions
and warnings.
The Spinal System is a set of instruments and implants for the surgical ap-proaches of deformity, degenerative and trauma indications.
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Product featuresPedicular Screw :
Locking Nut Single size Stable thread pro le Unique rotating
saddle design or single piece
Screw Head
Unique thread design Low pro le Color code by size Reduction & Non-Reduction Polyaxial and Monoaxial
Non-Reduction Screw Screw heads are color codedby screw diameter
Reduction Screw
The Spinal Fixation System is an internal xation device for spinal surgerycomprising of pedicle screws, connectors, rods, housings and transverse link assemblies. Variousforms and sizes of implants are available so that adaptations can be made to take into account thepathology and individual patient.
Screw Shaft Self-tapping design Diameters are from 4.5mm to 8.5mm Increased pull-out strength
Easy rod capture (50 rom)
4.5mm 5.5mm 6.5mm 7.5mm
Single PieceSet Screw(Optional)
Set Screw
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Product featuresCross-Link :
Rotaion
T r a n s l
a t i o n
Angulation
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Indications / Contraindications :
Indications
Contraindications(Contraindications include, but are not limited to) :
1 Degenerative spondylolisthesis2 Fracture3 DDD (con rmed by patient history and radiographic studies)4 Spinal tumors5 Dislocation6 Scoliosis
7 Kyphosis8 Failed previous fusion9 Having severe spondylolisthesis (Grades 3 and 4) of the fth lumbar- rst
sacral (L5-S1) vertebral joint10 Who are receiving fusions using autogenous bone graft only11 Who are having the device xed or attached to the lumbar and sacral spine
(L3 and below)12 Who are having the device removed after the development of a solid
fusion mass
1 Active infectious process or signi cant risk of infection (immunocompromise)2 Signs of local in ammation3 Fever or leukocytosis4 Morbid obesity5 Pregnancy6 Mental illness7 Grossly distorted anatomy caused by congenital abnormalities.8 Any other medical or surgical condition which would preclude the potential
bene t of spinal implant surgery.9 Rapid joint disease, bone absorption, osteopenia, osteomalacia and/or
osteoporosis. Osteoporosis or osteopenia is a relative contraindication sincethis condition may limit the degree of obtainable correction, stabilization,and/or the amount of mechanical xation.
10 Suspected or documented metal allergy or intolerance.11 Any case not needing a bone graft and fusion.12 Any case where the implant components selected for use would be too large
or too small to achieve a successful result.13 Any case that requires the mixing of metals from two different components
or systems.14 Any patient having inadequate tissue coverage over the operative site or
inadequate bone stock or quality.15 Any patient in which implant utilization would interfere with anatomical
structures or expected physiological performance.16 Any patient unwilling to follow postoperative instructions.
When used as a xation system of the non-cervical posterior spine in skeletally mature patients,
the Spine System is indicated for one or more of the following:
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Con rm by using the Tester whether the
created screw hole has deviated out of the bone or not.
Determine the screw insertion point, and use the
starter Awl to drill a hole into the cortical bone in
the decided position. AWL SCC 110-0211
TESTER SCC110-0410
Surgical Technique :
Step 1 : Creating a screw hole
Instrument :
SCC110-0211 AWL
SCC110-0311 Probe(Straight)
SCC110-0410 Tester
Insert the pedicle probe into the hole , and gently
push it into the pedicle.
PROBE (STRAIGHT)
SCC110-0311
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Step 2 : Radiograhic control
Instrument :
SCC110-0110 Guide Pin 100mm
SCC110-0120 Guide Pin 100mm w.Stop
When implementing radiographic control meas-
ures, use the pedicle marker.
Step 3 : Tapping
Instrument :
SCC110-0540/C Tap 4.5mm
SCC110-0550/C Tap 5.5mm
SCC110-0560/C Tap 6.5mm
SCC110-0570/C Tap 7.5mm
SCC110-0580/C Tap 8.5mm
SCC110-0410 Tester
Carry out tapping using the tap, the size of which
should match that of the screw. The screw is not a
self-tapping type. After recon rming by using the
Tester.
GUIDE PIN 100 SCC110-0110
GUIDE PIN 100+STOP SCC110-0120
TAP SCC110-0XXX
TESTER SCC110-0410
Surgical Technique :
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Step 5 : Bending and attaching the rod
Instrument :
SCC110-1520 French Bender
It is not possible to obtain a suf cient tighteningstrength at the connection unless the rod securelytouches the screw head bottom. For a safe connec-tion, bend the rod appropriately. ( see g I , II , III )
This operation is particularly Important when usingthe monoaxial screw.
Step 4 : Screw insertion
Instrument :
SCC110-0951 Polyaxial Screw Driver Shaft
SCC110-0955 Monoaxial Screw driver Shaft
SCC110-2425 M Screw driver (Medium)
SCC110-0951C Polyaxial Screw Driver Shaft , Cannulated
SCC110-0955C Monoaxial Screw driver Shaft , Cannulated
Attach the screwdriver to the screw. The screw-
driver is equipped with a merchanism to safely
grasp the screw. After the screw is inserted, the
driver comes off from the screw when turning the
Nut counter clockwise.
Fig. I Fig. II Fig. III
FRENCH BENDERSCC110-1520
Surgical Technique :
POLYAXIAL SCRE WDRIVER SHAFT SCC110-0951/C
SCREWDRIVER (MEDIUM) SCC110-2425M
MONOAXIAL SCREWDRIVER SHAFT SCC110-0955/C
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Step 6 : Rod insertion
Instrument :
SCC110-1211 Rod Holder
Attatch the rod to the screw head by use of a RodHolder.
ROD HOLDERSCC110-1211
Surgical Technique :
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Step 7 : Insert the Set Screw
When the rod is not securely touching the screwhead base,(Fig.2) suf cient tightening strenghcannot be obtained at the connection. For a safeconection, it is necessary to push the rod into thescrew bottom.
To attach the screw and the rod closely,the rod
pusher or the rod fork.
This operation to push the rod into the screwbottom is especially important when using the
monoaxial screw.
Self holding
Fig. I Fig. II
ROD PUSHERSCC110-1711
ROD FORKSCC110-1810
Surgical Technique :
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Step 8 : Insert the Set Screw(2)
Instrument :
SCC 110-1711 Rod Pusher
SCC 110-1810 Rod Fork
SCC 110-1920 Persuader
Before putting the plug into the screw,con rm that the rod is securely touching the screwhead bottom as shown in the left gure marked with"O" . In the case marked with "X", make sure that the
rod securely touches the screw headbottom in place, by bending or pushing the rod place,by using the rod approximator.
Fig. I Fig. II
ROD PUSHERSCC110-1711
PERSUADERSCC110-1920
ROD FORK (Adjustable)SCC110-1810
Surgical Technique :
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Surgical Technique :
Step 9 : Compression / Distraction
Instrument :
SCC110-2711 Compressor
SCC110-1311 Rod Clamp
SCC110-2811 Distractor
Use the distraction forceps to distract the constructinto the desired position. Then provisionally tightenthe set screw. Once distraction is achieved in alllevels nal tighten all set screws.
Use the compression forceps to compress theconstruct into the desired position. then proci-sionally tighten the set screw. Once distraction isachieved in all levels nal tighten all set screws.
Final tightening illustrated in step 10
Compressor SCC110-2711
Rod campSCC110-1311
Distractor SCC110-2811
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Step 10 : Tightening of the Set Screw
Instrument :
SCC110-2441 T-handle(Torque-limiter)
SCC110-2420 S Screw driver (small)
SCC110-2425 M Screw driver (medium)
SCC110-2430 L Screw driver (Large)
SCC110-2911 Anti-torque wrench
For the nal tightening of the Set Screw, use thetorque driver, the driver shaft, and the anti rotator handle.Procedure for using a torque-limiting driver isshown here as example.
Attach the anti rotator to the screw head and insertthe driver shaft to tighten the Set Screw. The driver clicks and runs idle when it reaches the prescribedtorque of 12 NM.
T-hadle(Torque-limiter)SCC110-2441
Screw driver (medium)SCC110-2420 SSCC110-2425 MSCC110-2430 L
Anti-torque wrenchSCC-110-2911
Surgical Technique :
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Implants :
Mono-Axial Screw 4.5mm Reduction
MSR 08-4520 20mm
MSR 08-4525 25mm
MSR 08-4530 30mm
MSR 08-4535 35mm
MSR 08-4540 40mm
MSR 08-4545 45mm
MSR 08-4550 50mm
MSR 08-4555 55mm
MSR 08-4560 60mm
Mono-Axial Screw 5.5mm Reduction
MSR 09-5520 20mm
MSR 09-5525 25mm
MSR 09-5530 30mm
MSR 09-5535 35mm
MSR 09-5540 40mm
MSR 09-5545 45mm
MSR 09-5550 50mm
MSR 09-5555 55mm
MSR 09-5560 60mm
Ordering Information :Mono-Axial Reduction Screws :
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Implants :
Mono-Axial Screw 6.5mm Reduction
MSR 10-6520 20mm
MSR 10-6525 25mm
MSR 10-6530 30mm
MSR 10-6535 35mm
MSR 10-6540 40mm
MSR 10-6545 45mm
MSR 10-6550 50mm
MSR 10-6555 55mm
MSR 10-6560 60mm
Mono-Axial Screw 7.5mm Reduction
MSR 11-7520 20mm
MSR 11-7525 25mm
MSR 11-7530 30mm
MSR 11-7535 35mm
MSR 11-7540 40mm
MSR 11-7545 45mm
MSR 11-7550 50mm
MSR 11-7555 55mm
MSR 11-7560 60mm
Ordering Information :Mono-Axial Reduction Screws :
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Implants :
Mono-Axial Screw 4.5mm Non-Reduction
MSS 08-4520 20mm
MSS 08-4525 25mm
MSS 08-4530 30mm
MSS 08-4535 35mm
MSS 08-4540 40mm
MSS 08-4545 45mm
MSS 08-4550 50mm
MSS 08-4555 55mm
MSS 08-4560 60mm
Mono-Axial Screw 5.5mm Non-Reduction
MSS 09-5520 20mm
MSS 09-5525 25mm
MSS 09-5530 30mm
MSS 09-5535 35mm
MSS 09-5540 40mm
MSS 09-5545 45mm
MSS 09-5550 50mm
MSS 09-5555 55mm
MSS 09-5560 60mm
Ordering Information :Mono-Axial Non-Reduction Screws :
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Implants :
Mono-Axial Screw 6.5mm Non-Reduction
MSS 10-6520 20mm
MSS 10-6525 25mm
MSS 10-6530 30mm
MSS 10-6535 35mm
MSS 10-6540 40mm
MSS 10-6545 45mm
MSS 10-6550 50mm
MSS 10-6555 55mm
MSS 10-6560 60mm
Mono-Axial Screw 7.5mm Non-Reduction
MSS 11-7520 20mm
MSS 11-7525 25mm
MSS 11-7530 30mm
MSS 11-7535 35mm
MSS 11-7540 40mm
MSS 11-7545 45mm
MSS 11-7550 50mm
MSS 11-7555 55mm
MSS 11-7560 60mm
Ordering Information :Mono-Axial Non-Reduction Screws :
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Implants :
Poly-Axial Screw 4.5mm Reduction
PSR 08-4520 20mm
PSR 08-4525 25mm
PSR 08-4530 30mm
PSR 08-4535 35mm
PSR 08-4540 40mm
PSR 08-4545 45mm
PSR 08-4550 50mm
PSR 08-4555 55mm
PSR 08-4560 60mm
Poly-Axial Screw 5.5mm Reduction
PSR 09-5520 20mm
PSR 09-5525 25mm
PSR 09-5530 30mm
PSR 09-5535 35mm
PSR 09-5540 40mm
PSR 09-5545 45mm
PSR 09-5550 50mm
PSR 09-5555 55mm
PSR 09-5560 60mm
Ordering Information :Poly-Axial Reduction Screws :
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Ordering Information :Poly-Axial Reduction Screws :
Implants :
Poly-Axial Screw 6.5mm Reduction
PSR 10-6520 20mm
PSR 10-6525 25mm
PSR 10-6530 30mm
PSR 10-6535 35mm
PSR 10-6540 40mm
PSR 10-6545 45mm
PSR 10-6550 50mm
PSR 10-6555 55mm
PSR 10-6560 60mm
Poly-Axial Screw 7.5mm Reduction
PSR 11-7520 20mm
PSR 11-7525 25mm
PSR 11-7530 30mm
PSR 11-7535 35mm
PSR 11-7540 40mm
PSR 11-7545 45mm
PSR 11-7550 50mm
PSR 11-7555 55mm
PSR 11-7560 60mm
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Implants :
Poly-Axial Screw 4.5mm Non-Reduction
PSS 08-4520 20mm
PSS 08-4525 25mm
PSS 08-4530 30mm
PSS 08-4535 35mm
PSS 08-4540 40mm
PSS 08-4545 45mm
PSS 08-4550 50mm
PSS 08-4555 55mm
PSS 08-4560 60mm
Poly-Axial Screw 5.5mm Non-Reduction
PSS 09-5520 20mm
PSS 09-5525 25mm
PSS 09-5530 30mm
PSS 09-5535 35mm
PSS 09-5540 40mm
PSS 09-5545 45mm
PSS 09-5550 50mm
PSS 09-4555 55mm
PSS 09-5560 60mm
Ordering Information :Poly-Axial Non-Reduction Screws :
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Ordering Information :Set screw and Cross-Link :
Set screw
CHM01-10 With Saddle
CHM01-12 Without Saddle
Crosslink
SCC0120-0035
Range
40-45 mm
SCC0120-0042 45-55 mm
SCC0120-0050 55-65 mm
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Implants :
Dynamic Poly-Axial Screw 4.5mm Reduction
DPR08-4520 20mm
DPR08-4525 25mm
DPR08-4530 30mm
DPR08-4535 35mm
DPR08-4540 40mm
DPR08-4545 45mm
DPR08-4550 50mm
DPR08-4555 55mm
DPR08-4560 60mm
Dynamic Poly-Axial Screw 5.5mm Reduction
DPR09-5520 20mm
DPR09-5525 25mm
DPR09-5530 30mm
DPR09-5535 35mm
DPR09-5540 40mm
DPR09-5545 45mm
DPR09-5550 50mm
DPR09-5555 55mm
DPR09-5560 60mm
Ordering Information :Dynamic Poly-Axial Reduction Screws: Non-fusion
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Ordering Information :Dynamic Poly-Axial Reduction Screws: Non-fusion
Implants :
Dynamic Poly-Axial Screw 6.5mm Reduction
DPR10-6520 20mm
DPR10-6525 25mm
DPR10-6530 30mm
DPR10-6535 35mm
DPR10-6540 40mm
DPR10-6545 45mm
DPR10-6550 50mm
DPR10-6555 55mm
DPR10-6560 60mm
Dynamic Poly-Axial Screw 7.5mm Reduction
DPR11-7520 20mm
DPR11-7525 25mm
DPR11-7530 30mm
DPR11-7535 35mm
DPR11-7540 40mm
DPR11-7545 45mm
DPR11-7550 50mm
DPR11-7555 55mm
DPR11-7560 60mm
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Implants :
Dynamic Poly-Axial Screw 4.5mm Non-Reduction
DPS08-4520 20mm
DPS08-4525 25mm
DPS08-4530 30mm
DPS08-4535 35mm
DPS08-4540 40mm
DPS08-4545 45mm
DPS08-4550 50mm
DPS08-4555 55mm
DPS08-4560 60mm
Dynamic Poly-Axial Screw 5.5mm Non-Reduction
DPS09-5520 20mm
DPS09-5525 25mm
DPS09-5530 30mm
DPS09-5535 35mm
DPS09-5540 40mm
DPS09-5545 45mm
DPS09-5550 50mm
DPS09-5555 55mm
DPS09-5560 60mm
Ordering Information :Dynamic Poly-Axial Non-Reduction Screws : Non-fusion
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Ordering Information :Dynamic Poly-Axial Non-Reduction Screws : Non-fusion
Implants :
Dynamic Poly-Axial Screw 6.5mm Non-Reduction
DPS10-6520 20mm
DPS10-6525 25mm
DPS10-6530 30mm
DPS10-6535 35mm
DPS10-6540 40mm
DPS10-6545 45mm
DPS10-6550 50mm
DPS10-6555 55mm
DPS10-6560 60mm
Dynamic Poly-Axial Screw 7.5mm Non-Reduction
DPS11-7520 20mm
DPS11-7525 25mm
DPS11-7530 30mm
DPS11-7535 35mm
DPS11-7540 40mm
DPS11-7545 45mm
DPS11-7550 50mm
DPS11-7555 55mm
DPS11-7560 60mm
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Ordering Information :Rod to rod connectors :
Implants :
Extention connector EC1-0001
Parallel connector PC-1-0001
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Ti Rod (Straight)
SCC02-0040 40mm
SCC02-0050 50mm
SCC02-0060 60mm
SCC02-0070 70mm
SCC02-0080 80mm
SCC02-0090 90mm
SCC02-0100 100mmSCC02-0110 110mm
SCC02-0120 120mm
SCC02-0130 130mm
SCC02-0140 140mm
SCC02-0150 150mm
SCC02-0160 160mm
SCC02-0170 170mm
SCC02-0180 180mm
SCC02-0190 190mm
SCC02-0200 200mm
SCC02-0250 250mm
SCC02-0300 300mm
SCC02-0350 350mm
SCC02-0400 400mm
SCC02-0500 500mmSCC02-0600 600mm
Ordering Information :Rods :
Ti rod curved
SCC03-0080 80mm
SCC03-0120 120mm
SCC03-0160 160mm
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Narrow laminar hook
HS21-0504 20mm
HS21-0505 21mm
HS21-0506 22mm
HS21-0507 23mm
HS21-0508 24mm
HS21-0509 25mm
HS21-0510 26mm
Pedicle hook
HS20-0804 20mm
HS20-0805 21mm
HS20-0806 22mm
HS20-0807 23mm
HS20-0808 24mm
HS20-0809 25mm
HS20-0810 26mm
Ordering Information :Hooks :
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Wide larminar hook
HS22-0704 20mm
HS22-0705 21mm
HS22-0706 22mm
HS22-0707 23mm
HS22-0708 24mm
HS22-0709 25mm
HS22-0710 26mm
Angled larminar hook
HS23-0505 20mm
HS23-0507 21mm
HS23-0509 22mm
HS23-0511 23mm
HS22-0505 24mm
HS22-0507 25mm
HS22-0509 27mm
HS22-0511 29mm
Ordering Information :Hooks :
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Laminar hook (Left)
HS25-0505 24mm
HS25-0507 26mm
HS25-0509 28mm
HS25-0511 30mm
Laminar hook (Right)
HS26-0505 24mm
HS26-0507 26mm
HS26-0509 28mm
HS26-0511 30mm
Laminar hook w. Extended body
HS27-0504 23.5mm
HS27-0505 24.5mm
HS27-0506 25.5mm
HS27-0507 26.5mm
HS27-0508 27.5mm
HS27-0509 28.5mm
HS27-0510 29.5mm
Ordering Information :Hooks :
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Implants :
SCC110-0110 GUIDE PIN 100mm
SCC110-0120 GUIDE PIN 100mm W.STOP
Ordering Information :Instruments :Pins :
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SCC110-0211 AWL
SCC110-0321 PROBE (CURVED)
Ordering Information :Instruments :
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SCC110-0410 TESTER
Ordering Information :Instruments :
SCC110-0311 PROBE (STRAIGHT)
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SCC110-0630 T-HANDLE LARGE
SCC112-0610 T-HANDLE SMALL
SCC110-2441 TORQUE LIMITINGT-HANDLE
12 nm
Ordering Information :Instruments :
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SCC110-0640 I-HANDLE
SCC110-0641 EXTENDED I-HANDLE
Ordering Information :Instruments :
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TAP : NON-CANNULATED
SCC110-0540 4.5mm
SCC110-0550 5.5mm
SCC110-0560 6.5mm
SCC110-0570 7.5mm
TAP : CANNULATED
SCC110-0540C 4.5mm
SCC110-0550C 5.5mm
SCC110-0560C 6.5mm
SCC110-0570C 7.5mm
Rod Template
RT-1-0001 200 mm
Ordering Information :Instruments :
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SCC110-0951
SCC110-0955
POLY-AXIAL SCREWDRIVER SHAFT
MONO-AXIAL SCREWDRIVER SHAFT
SCC110-0951C POLY-AXIAL SCREWDRIVER SHAFT , CANNULATED
SCC110-0955C MONO-AXIAL SCREW
DRIVER SHAFT , CANNULATED
SCC110-2420 S SCREW DRIVER (SMALL)
SCC110-2425 M SCREW DRIVER (MEDIUM)SCC110-2430 L SCREW DRIVER (LARGE)
SCC110-3311 TRANSVERSE WRENCH TIP
Ordering Information :Instruments :
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SCC110-1311 ROD CLAMP
SCC110-1520 FRENCH BENDER
Ordering Information :Instruments :
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SCC110-1531 IN-SITU BENDER (L)
SCC110-1541 IN-SITU BENDER (R)
Ordering Information :Instruments :
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SCC110-1711 ROD PUSHER
SCC110-1810 ROD FORK (Adjustable)
Ordering Information :Instruments :
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SCC110-2911 ANTI-TORQUE WRENCH
SCC110-1920 PERSUADER
SCC110-2430 SCREW HOLDER
Ordering Information :Instruments :
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SCC110-0105 Instrument tray 1
SCC110-0106 Instrument tray 2
SCC110-0100 Container for instruments
Ordering Information :Containers & Trays :
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SCC110-0102 TRAY RODS 1(INCL. COVERING PLATE)
SCC110-0103 TRAY HOOKS 2(INCL. COVERING PLATE)
Ordering Information :Trays :
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SCC110-0104 Screw caddy
SCC110-0101 Container for spinal implants
Ordering Information :Containers & Trays :
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SCC110-0107 SPARE-LID(FOR SCC 110-0102 / 0103)
Ordering Information :Lid :
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