MC2P ACETABULAR COMPONENT

Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

OSTEONICS CORP.

The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Mc2p Acetabular Component.

Pre-market Notification Details

Device IDK900438
510k NumberK900438
Device Name:MC2P ACETABULAR COMPONENT
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Applicant OSTEONICS CORP. 59 ROUTE 17 Allendale,  NJ  07401 -1677
ContactPat Kramer
CorrespondentPat Kramer
OSTEONICS CORP. 59 ROUTE 17 Allendale,  NJ  07401 -1677
Product CodeJDI  
CFR Regulation Number888.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-01-30
Decision Date1990-04-18

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