OSTEONICS MODULAR ACETABULAR CUP (MICROSTRUCTURED VERSION)

Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented

OSTEONICS CORP.

The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Osteonics Modular Acetabular Cup (microstructured Version).

Pre-market Notification Details

Device IDK963946
510k NumberK963946
Device Name:OSTEONICS MODULAR ACETABULAR CUP (MICROSTRUCTURED VERSION)
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant OSTEONICS CORP. 59 ROUTE 17 Allendale,  NJ  07401 -1677
ContactTerry Sheridan
CorrespondentTerry Sheridan
OSTEONICS CORP. 59 ROUTE 17 Allendale,  NJ  07401 -1677
Product CodeLPH  
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-10-02
Decision Date1997-01-27
Summary:summary

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