VERSYS HIP SYSTEM--FIBER METAL TAPER HIP PROSTHESIS

Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

ZIMMER, INC.

The following data is part of a premarket notification filed by Zimmer, Inc. with the FDA for Versys Hip System--fiber Metal Taper Hip Prosthesis.

Pre-market Notification Details

• Device ID: K964769
• 510k Number: K964769
• Device Name: VERSYS HIP SYSTEM--FIBER METAL TAPER HIP PROSTHESIS
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
• Applicant: ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708
• Contact: Karen Cain
• Correspondent: Karen Cain; ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708
• Product Code: LPH
• CFR Regulation Number: 888.3358 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-11-27
• Decision Date: 1997-02-13
• Summary: summary

NIH GUDID Devices

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