OSTEONICS FLANGED POLYETHYLENE ACETABULAR CUP

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 Flanged Polyethylene Acetabular Cup.

Pre-market Notification Details

Device IDK963671
510k NumberK963671
Device Name:OSTEONICS FLANGED POLYETHYLENE ACETABULAR CUP
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Applicant OSTEONICS CORP. 59 ROUTE 17 Allendale,  NJ  07401 -1677
ContactTerry Sheridan
CorrespondentTerry Sheridan
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 Received1996-09-13
Decision Date1997-02-03
Summary:summary

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