GMK REVISION KNEE SYSTEM

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 Revision Knee System.

Pre-market Notification Details

• Device ID: K102437
• 510k Number: K102437
• Device Name: GMK REVISION KNEE SYSTEM
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: MEDACTA INTERNATIONAL, SA 13721 VIA TRES VISTA San Diego, CA 92129
• Contact: Natalie J Kennel
• Correspondent: Natalie J Kennel; MEDACTA INTERNATIONAL, SA 13721 VIA TRES VISTA San Diego, CA 92129
• Product Code: JWH
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-08-26
• Decision Date: 2010-09-24
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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