TRABECULAR METAL REVISION SHELL LINERS

Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

ZIMMER, INC.

The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Trabecular Metal Revision Shell Liners.

Pre-market Notification Details

• Device ID: K051516
• 510k Number: K051516
• Device Name: TRABECULAR METAL REVISION SHELL LINERS
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
• Applicant: ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708
• Contact: Tony Kingsley
• Correspondent: Tony Kingsley; ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708
• Product Code: JDI
• CFR Regulation Number: 888.3350 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-06-08
• Decision Date: 2005-07-27
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00889024129023	K051516	000
00889024129184	K051516	000
00889024129191	K051516	000
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