GAMMA SYSTEM

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 Gamma System.

Pre-market Notification Details

• Device ID: K955473
• 510k Number: K955473
• Device Name: GAMMA SYSTEM
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
• Applicant: ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708
• Contact: Angie Iide
• Correspondent: Angie Iide; ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708
• Product Code: JDI
• Subsequent Product Code: KWL
• Subsequent Product Code: LWJ
• CFR Regulation Number: 888.3350 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-11-30
• Decision Date: 1996-02-16

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00889024362185	K955473	000
00889024135987	K955473	000
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