GLOBAL MODULAR REPLACEMENT SYSTEM PEDIATRIC TIBIAL BEARING COMPONENT

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 Pediatric Tibial Bearing Component.

Pre-market Notification Details

• Device ID: K031480
• 510k Number: K031480
• Device Name: GLOBAL MODULAR REPLACEMENT SYSTEM PEDIATRIC TIBIAL BEARING COMPONENT
• Classification: Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer
• Applicant: HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401
• Contact: Margaret F Crowe
• Correspondent: Margaret F Crowe; HOWMEDICA OSTEONICS CORP. 59 ROUTE 17 SOUTH Allendale, NJ 07401
• Product Code: KRO
• CFR Regulation Number: 888.3510 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-05-12
• Decision Date: 2003-07-31
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07613327048230	K031480	000