WAGNER CONE PROSTHESIS

Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

CENTERPULSE ORTHOPEDICS, INC.

The following data is part of a premarket notification filed by Centerpulse Orthopedics, Inc. with the FDA for Wagner Cone Prosthesis.

Pre-market Notification Details

• Device ID: K032380
• 510k Number: K032380
• Device Name: WAGNER CONE PROSTHESIS
• Classification: Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
• Applicant: CENTERPULSE ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin, TX 78717
• Contact: Robert M Wolfarth
• Correspondent: Robert M Wolfarth; CENTERPULSE ORTHOPEDICS, INC. 9900 SPECTRUM DR. Austin, TX 78717
• Product Code: LZO
• CFR Regulation Number: 888.3353 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-08-01
• Decision Date: 2003-09-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00889024282308	K032380	000
00889024282179	K032380	000
00889024282162	K032380	000
00889024282155	K032380	000
00889024282148	K032380	000
00889024282131	K032380	000
00889024282124	K032380	000
00889024282117	K032380	000
00889024282100	K032380	000
00889024282094	K032380	000
00889024282087	K032380	000
00889024282186	K032380	000
00889024282193	K032380	000
00889024282292	K032380	000
00889024282285	K032380	000
00889024282278	K032380	000
00889024282261	K032380	000
00889024282254	K032380	000
00889024282247	K032380	000
00889024282230	K032380	000
00889024282223	K032380	000
00889024282216	K032380	000
00889024282209	K032380	000
00889024282070	K032380	000