RESTORATION HA ACETABULAR CUP SERIES

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

OSTEONICS CORP.

The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Restoration Ha Acetabular Cup Series.

Pre-market Notification Details

Device IDK943957
510k NumberK943957
Device Name:RESTORATION HA ACETABULAR CUP SERIES
ClassificationProsthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
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 CodeMEH  
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-08-15
Decision Date1995-03-06

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