GMK Spherika Femurs And Fixed Tibial Trays Plus

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

Medacta International SA

The following data is part of a premarket notification filed by Medacta International Sa with the FDA for Gmk Spherika Femurs And Fixed Tibial Trays Plus.

Pre-market Notification Details

• Device ID: K211004
• 510k Number: K211004
• Device Name: GMK Spherika Femurs And Fixed Tibial Trays Plus
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/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: JWH
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-04-02
• Decision Date: 2021-05-13

NIH GUDID Devices

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