OMNIFIT DISTAL STEM CEMENT SPACERS

Prosthesis, Hip, Cement Restrictor

OSTEONICS CORP.

The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Omnifit Distal Stem Cement Spacers.

Pre-market Notification Details

Device IDK872528
510k NumberK872528
Device Name:OMNIFIT DISTAL STEM CEMENT SPACERS
ClassificationProsthesis, Hip, Cement Restrictor
Applicant OSTEONICS CORP. 59 ROUTE 17 Allendale,  NJ  07401 -1677
ContactDennis H Crane
CorrespondentDennis H Crane
OSTEONICS CORP. 59 ROUTE 17 Allendale,  NJ  07401 -1677
Product CodeJDK  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-06-25
Decision Date1987-12-29

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