ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS

Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate

HOWMEDICA OSTEONICS CORP

The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for Adm And Adm/mdm Duration Inserts, Adm And Adm/mdm X3 Inserts.

Pre-market Notification Details

Device IDK112556
510k NumberK112556
Device Name:ADM AND ADM/MDM DURATION INSERTS, ADM AND ADM/MDM X3 INSERTS
ClassificationProsthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Applicant HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah,  NJ  07430
ContactValerie Giambanco
CorrespondentValerie Giambanco
HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah,  NJ  07430
Product CodeMEH  
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-09-02
Decision Date2011-09-28
Summary:summary

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