GLOBAL MODULAR REPLACEMENT SYSTEM ANTEVERTED PROMIMAL FEMORAL COMPONENT

Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

HOWMEDICA OSTEONICS CORP.

The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Global Modular Replacement System Anteverted Promimal Femoral Component.

Pre-market Notification Details

• Device ID: K032581
• 510k Number: K032581
• Device Name: GLOBAL MODULAR REPLACEMENT SYSTEM ANTEVERTED PROMIMAL FEMORAL COMPONENT
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
• Applicant: HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677
• Contact: Margaret F Crowe
• Correspondent: Margaret F Crowe; HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401 -1677
• Product Code: LPH
• CFR Regulation Number: 888.3358 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-08-21
• Decision Date: 2003-10-09
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07613327049800	K032581	000
07613327048766	K032581	000
07613327048735	K032581	000
07613327048728	K032581	000