MODIFICATION TO MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEMS

Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented

HOWMEDICA OSTEONICS CORP

The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for Modification To Modular Replacement System (mrs) Humeral Stems.

Pre-market Notification Details

Device IDK040128
510k NumberK040128
Device Name:MODIFICATION TO MODULAR REPLACEMENT SYSTEM (MRS) HUMERAL STEMS
ClassificationProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
Applicant HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah,  NJ  07430
ContactMargaret F Crowe
CorrespondentMargaret F Crowe
HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah,  NJ  07430
Product CodeHSD  
CFR Regulation Number888.3690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-01-21
Decision Date2004-03-26
Summary:summary

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