Capabilities of Komet Medical Germany. · 2019-03-05 · · EDM-Wire · Wire forming · CMM...

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Capabilities of Komet Medical Germany.

Transcript of Capabilities of Komet Medical Germany. · 2019-03-05 · · EDM-Wire · Wire forming · CMM...

Capabilities of Komet Medical Germany.

Facts & Figures

Production

· Founded: 1923· Brand: Komet/Komet Medical · Independent family-owned company· Certified according to: ISO 9001:2015, EN ISO 13485:2016 and ISO 13485:2016 (MDSAP)· FDA Establishment Reg No. 8010468· Staff: > 1,100 in Lemgo → > 1,350 worldwide· Floor area: > 44,500 qm/480,000 sqft production area and office space · Cleanroom ISO 7/8 with integrated ultrasonic cleaning · No. of production units > 860

· 6-axis grinding machines· CNC controlled long automatic lathes (max. Ø 32 mm)· Lathe/milling center with 5 simultaneous axes for titanium (max. Ø 42 mm)· Profile grinding· Gun drilling (Q4 2019)· High-performance phase laser cutting – saw blades etc.· Offsetting machines for the production of saw blades· Surface treatment· Laserwelding· Anodizing· Electropolishing· Vibratory finishing· Deburring· Heat treatment· Ultrasonic cleaning· Passivation (ASTM A967)

· EDM-Wire· Wire forming· CMM Inspection· Electrodynamic testing machine according to ASTM F1717, ASTM F2193, ISO 12189 · Torsion testing machine according to ASTM F543, ASTM F1717, ASTM 1798· Diamond coating · Gold plating · Color coding · Lasermarking· Bead blasting/Satin finish · Cleanroom packaging · Warehousing

Komet Medical Capabilities 2019

Saw Blades· ground blades (kneeblades)· offset blades · etched

High-/Low Speed Burs· Stainless steel· Tungsten Carbide-/stainless steel combination· Fullcarbide · Diamond

Drill Bits/Twist Drills + Cannulated DrillsRaspsPins + Screws for endoprosthesis (510(k): K131264)Steinmann Pins + K-Wires (510(k): K131264)Titanium Implants

· Pedicle Screw SystemsCore

Products

· Private Label or Contract Manufacturing· Process validation· Cleaning validation· Packaging validation· Sterile validation· Statistical process control (SPC/CAQ)· CAD/CAM integrated process between Design-Engineering and production

Documentation Validation

Quality Control

Komet Medical Capabilities 2019

Komet Italia S.r.l. · Via Fabio Filzi 2 · 20124 Milano · Telefono 02 67076654 · Telefax 02 67479318 · [email protected] · www.komet.it

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www.kometmedical.de

Komet Medical Trophagener Weg 25 · 32657 Lemgo Postfach 160 · 32631 Lemgo · Germany

Telefon +49 (0) 5261 701-400 Telefax +49 (0) 5261 701-580

[email protected] www.kometmedical.de