ZIMMER UNICOMPARTMENTAL KNEE SYSTEM VIVACIT-E ARTICULAR SURFACE

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

ZIMMER, INC.

The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Zimmer Unicompartmental Knee System Vivacit-e Articular Surface.

Pre-market Notification Details

• Device ID: K122529
• 510k Number: K122529
• Device Name: ZIMMER UNICOMPARTMENTAL KNEE SYSTEM VIVACIT-E ARTICULAR SURFACE
• Classification: Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
• Applicant: ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708
• Contact: Mark D Warner
• Correspondent: Mark D Warner; ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708
• Product Code: HSX
• CFR Regulation Number: 888.3520 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-08-20
• Decision Date: 2012-11-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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