OSTEONICS(R) ARC DEPOSITIONED FEMORAL COMPONENTS

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 Osteonics(r) Arc Depositioned Femoral Components.

Pre-market Notification Details

Device IDK930187
510k NumberK930187
Device Name:OSTEONICS(R) ARC DEPOSITIONED FEMORAL COMPONENTS
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Applicant OSTEONICS CORP. 59 ROUTE 17 Allendale,  NJ  07401 -1677
ContactRobert A Koch
CorrespondentRobert A Koch
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 Received1993-01-14
Decision Date1994-03-03

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