OSTEONICS RESTORATION CEMENTED HIP STEM SERIES

Prosthesis, Hip, Hemi-, Femoral, Metal

OSTEONICS CORP.

The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Osteonics Restoration Cemented Hip Stem Series.

Pre-market Notification Details

Device IDK943778
510k NumberK943778
Device Name:OSTEONICS RESTORATION CEMENTED HIP STEM SERIES
ClassificationProsthesis, Hip, Hemi-, Femoral, Metal
Applicant OSTEONICS CORP. 59 ROUTE 17 Allendale,  NJ  07401 -1677
ContactRobert A Koch, J.d.
CorrespondentRobert A Koch, J.d.
OSTEONICS CORP. 59 ROUTE 17 Allendale,  NJ  07401 -1677
Product CodeKWL  
CFR Regulation Number888.3360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-08-02
Decision Date1995-08-14

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