OMNIFIT TOTAL KNEE SERIES II TIBIAL INSERTS

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

OSTEONICS CORP.

The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Omnifit Total Knee Series Ii Tibial Inserts.

Pre-market Notification Details

Device IDK884398
510k NumberK884398
Device Name:OMNIFIT TOTAL KNEE SERIES II TIBIAL INSERTS
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant OSTEONICS CORP. 59 ROUTE 17 Allendale,  NJ  07401 -1677
ContactMichael B Sheldon
CorrespondentMichael B Sheldon
OSTEONICS CORP. 59 ROUTE 17 Allendale,  NJ  07401 -1677
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-10-19
Decision Date1989-01-17

NIH GUDID Devices

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