DEPUY GRADUATED COMPARTMENTAL KNEE (GCK)

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

DEPUY ORTHOPAEDICS, INC.

The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Graduated Compartmental Knee (gck).

Pre-market Notification Details

• Device ID: K061648
• 510k Number: K061648
• Device Name: DEPUY GRADUATED COMPARTMENTAL KNEE (GCK)
• Classification: Prosthesis, Knee Patellofemorotibial, Partial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: DEPUY ORTHOPAEDICS, INC. P.O. BOX 988 Warsaw, IN 46581 -0988
• Contact: Nancy Friddle
• Correspondent: Nancy Friddle; DEPUY ORTHOPAEDICS, INC. P.O. BOX 988 Warsaw, IN 46581 -0988
• Product Code: NPJ
• Subsequent Product Code: HRY
• Subsequent Product Code: KRR
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-06-13
• Decision Date: 2006-09-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10603295001652	K061648	000
10603295001874	K061648	000
10603295001881	K061648	000
10603295001898	K061648	000
10603295001904	K061648	000
10603295001928	K061648	000
10603295001935	K061648	000
10603295001942	K061648	000
10603295001959	K061648	000
10603295001966	K061648	000
10603295001973	K061648	000
10603295001980	K061648	000
10603295001997	K061648	000
10603295001867	K061648	000
10603295001850	K061648	000
10603295001843	K061648	000
10603295001836	K061648	000
10603295001911	K061648	000
10603295002192	K061648	000
10603295001614	K061648	000
10603295001621	K061648	000
10603295001638	K061648	000
10603295001645	K061648	000
10603295001669	K061648	000
10603295001676	K061648	000
10603295001683	K061648	000
10603295001690	K061648	000
10603295001706	K061648	000
10603295002000	K061648	000
10603295002017	K061648	000
10603295002178	K061648	000
10603295002185	K061648	000
10603295002208	K061648	000
10603295002215	K061648	000
10603295002222	K061648	000
10603295002239	K061648	000
10603295002246	K061648	000
10603295002253	K061648	000
10603295002260	K061648	000
10603295002277	K061648	000
10603295002284	K061648	000
10603295002291	K061648	000
10603295002161	K061648	000
10603295002154	K061648	000
10603295002147	K061648	000
10603295002024	K061648	000
10603295002031	K061648	000
10603295002048	K061648	000
10603295002055	K061648	000
10603295002062	K061648	000
10603295002079	K061648	000
10603295002086	K061648	000
10603295002093	K061648	000
10603295002109	K061648	000
10603295002116	K061648	000
10603295002123	K061648	000
10603295002130	K061648	000
10603295002307	K061648	000