SYSTEM 12 CONSTRAINED ACETABULAR LINERS

Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer

HOWMEDICA OSTEONICS CORP

The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for System 12 Constrained Acetabular Liners.

Pre-market Notification Details

• Device ID: K063550
• 510k Number: K063550
• Device Name: SYSTEM 12 CONSTRAINED ACETABULAR LINERS
• Classification: Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer
• Applicant: HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430
• Contact: Francisco Haro
• Correspondent: Francisco Haro; HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah, NJ 07430
• Product Code: KWZ
• CFR Regulation Number: 888.3310 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-11-24
• Decision Date: 2007-03-08
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
37613327579797	K063550	000
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