OMNIFIT TOTAL KNEE PROSTHESIS SYSTEM

Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer

OSTEONICS CORP.

The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Omnifit Total Knee Prosthesis System.

Pre-market Notification Details

Device IDK862837
510k NumberK862837
Device Name:OMNIFIT TOTAL KNEE PROSTHESIS SYSTEM
ClassificationProsthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
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 CodeHSX  
CFR Regulation Number888.3520 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-07-25
Decision Date1986-12-22

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07613327033939 K862837 000
07613327033922 K862837 000

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