OSTEONICS MICROSTRUCTURED ACETABULAR COMPONENTS

Mesh, Surgical, Acetabular, Hip, Prosthesis

OSTEONICS CORP.

The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Osteonics Microstructured Acetabular Components.

Pre-market Notification Details

Device IDK925883
510k NumberK925883
Device Name:OSTEONICS MICROSTRUCTURED ACETABULAR COMPONENTS
ClassificationMesh, Surgical, Acetabular, Hip, Prosthesis
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 CodeJDJ  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-11-19
Decision Date1993-06-15

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