GLOBAL MODULAR REPLACEMENT SYSTEM (GMRS)

Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer

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 (gmrs).

Pre-market Notification Details

• Device ID: K023087
• 510k Number: K023087
• Device Name: GLOBAL MODULAR REPLACEMENT SYSTEM (GMRS)
• Classification: Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
• 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: KRO
• CFR Regulation Number: 888.3510 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-09-17
• Decision Date: 2002-12-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07613327049831	K023087	000
07613327048919	K023087	000
07613327048896	K023087	000
07613327048865	K023087	000
07613327048858	K023087	000
07613327048841	K023087	000
07613327048834	K023087	000
07613327048827	K023087	000
07613327048810	K023087	000
07613327048803	K023087	000
07613327048797	K023087	000
07613327048780	K023087	000
07613327048773	K023087	000
07613327048759	K023087	000
07613327048711	K023087	000
07613327048704	K023087	000
07613327049121	K023087	000
07613327049145	K023087	000
07613327049824	K023087	000
07613327049299	K023087	000
07613327049282	K023087	000
07613327049275	K023087	000
07613327049268	K023087	000
07613327049251	K023087	000
07613327049244	K023087	000
07613327049237	K023087	000
07613327049220	K023087	000
07613327049213	K023087	000
07613327049206	K023087	000
07613327049190	K023087	000
07613327049176	K023087	000
07613327049169	K023087	000
07613327049152	K023087	000
07613327033687	K023087	000