CPT 12/14 HIP PROSTHESES, MODEL 00-8114-040/050-00

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 Cpt 12/14 Hip Prostheses, Model 00-8114-040/050-00.

Pre-market Notification Details

• Device ID: K030265
• 510k Number: K030265
• Device Name: CPT 12/14 HIP PROSTHESES, MODEL 00-8114-040/050-00
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
• Applicant: ZIMMER, INC. P.O. BOX 708 Warsaw, IN 46581 -0708
• Contact: Dalene T Binkley
• Correspondent: Dalene T Binkley; 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: 2003-01-27
• Decision Date: 2003-03-04
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00889024145979	K030265	000
00889024145962	K030265	000
00889024145955	K030265	000
00889024145948	K030265	000