GMK Revision & Hinge Extension - TiNbN Coating

Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer

Medacta International SA

The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Gmk Revision & Hinge Extension - Tinbn Coating.

Pre-market Notification Details

• Device ID: K210010
• 510k Number: K210010
• Device Name: GMK Revision & Hinge Extension - TiNbN Coating
• Classification: Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
• Applicant: Medacta International SA Strada Regina Castel San Pietro, CH Ch-6874
• Contact: Stefano Baj
• Correspondent: Chris Lussier; Medacta USA 3973 Delp Street Memphis, TN 83118
• Product Code: KRO
• CFR Regulation Number: 888.3510 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-01-04
• Decision Date: 2021-03-02

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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