ALPHA 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 Alpha System.

Pre-market Notification Details

• Device ID: K950312
• 510k Number: K950312
• Device Name: ALPHA SYSTEM
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
• Applicant: ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708
• Contact: Angie Ide
• Correspondent: Angie Ide; ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708
• Product Code: JDI
• CFR Regulation Number: 888.3350 [🔎]
• Decision: Substantially Equivalent For Some Indications (SN)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-01-26
• Decision Date: 1995-05-17

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00889024138667	K950312	000
00889024138223	K950312	000
00889024138216	K950312	000
00889024138209	K950312	000
00889024138193	K950312	000
00889024138186	K950312	000
00889024138179	K950312	000
00889024138162	K950312	000
00889024138155	K950312	000
00889024138148	K950312	000
00889024138131	K950312	000
00889024138124	K950312	000
00889024138117	K950312	000
00889024138100	K950312	000
00889024138094	K950312	000
00889024138087	K950312	000
00889024138070	K950312	000
00889024138230	K950312	000
00889024138247	K950312	000
00889024138254	K950312	000
00889024138414	K950312	000
00889024138407	K950312	000
00889024138391	K950312	000
00889024138384	K950312	000
00889024138377	K950312	000
00889024138360	K950312	000
00889024138353	K950312	000
00889024138346	K950312	000
00889024138339	K950312	000
00889024138322	K950312	000
00889024138315	K950312	000
00889024138308	K950312	000
00889024138292	K950312	000
00889024138285	K950312	000
00889024138278	K950312	000
00889024138261	K950312	000
00889024138063	K950312	000