DEPUY GCK TIBIAL COMPONENTS

Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer

DEPUY ORTHOPAEDICS, INC.

The following data is part of a premarket notification filed by Depuy Orthopaedics, Inc. with the FDA for Depuy Gck Tibial Components.

Pre-market Notification Details

• Device ID: K070267
• 510k Number: K070267
• Device Name: DEPUY GCK TIBIAL COMPONENTS
• Classification: Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer
• Applicant: DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46582
• Contact: Nancy Friddle
• Correspondent: Nancy Friddle; DEPUY ORTHOPAEDICS, INC. 700 ORTHOPAEDIC DR. Warsaw, IN 46582
• Product Code: HRY
• CFR Regulation Number: 888.3530 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-01-29
• Decision Date: 2007-08-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10603295002529	K070267	000
10603295002420	K070267	000
10603295002437	K070267	000
10603295002444	K070267	000
10603295002451	K070267	000
10603295002468	K070267	000
10603295002475	K070267	000
10603295002482	K070267	000
10603295002499	K070267	000
10603295002505	K070267	000
10603295002512	K070267	000
10603295002536	K070267	000
10603295002543	K070267	000
10603295002567	K070267	000
10603295002574	K070267	000
10603295002581	K070267	000
10603295002598	K070267	000
10603295002413	K070267	000
10603295002406	K070267	000
10603295002550	K070267	000
10603295002635	K070267	000
10603295002666	K070267	000
10603295002710	K070267	000
10603295002840	K070267	000
10603295002857	K070267	000
10603295002932	K070267	000
10603295002314	K070267	000
10603295002321	K070267	000
10603295002338	K070267	000
10603295002345	K070267	000
10603295002352	K070267	000
10603295002369	K070267	000
10603295002376	K070267	000
10603295002383	K070267	000
10603295002390	K070267	000
10603295002604	K070267	000
10603295002611	K070267	000
10603295002833	K070267	000
10603295002864	K070267	000
10603295002871	K070267	000
10603295002888	K070267	000
10603295002895	K070267	000
10603295002901	K070267	000
10603295002918	K070267	000
10603295002925	K070267	000
10603295002949	K070267	000
10603295002956	K070267	000
10603295002963	K070267	000
10603295002970	K070267	000
10603295002987	K070267	000
10603295002994	K070267	000
10603295003007	K070267	000
10603295003014	K070267	000
10603295002826	K070267	000
10603295002819	K070267	000
10603295002628	K070267	000
10603295002642	K070267	000
10603295002659	K070267	000
10603295002673	K070267	000
10603295002680	K070267	000
10603295002697	K070267	000
10603295002703	K070267	000
10603295002727	K070267	000
10603295002734	K070267	000
10603295002741	K070267	000
10603295002758	K070267	000
10603295002765	K070267	000
10603295002772	K070267	000
10603295002789	K070267	000
10603295002796	K070267	000
10603295002802	K070267	000
10603295003021	K070267	000