PT II DISTAL CEMENT SPACER

Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

OSTEONICS CORP.

The following data is part of a premarket notification filed by Osteonics Corp. with the FDA for Pt Ii Distal Cement Spacer.

Pre-market Notification Details

Device IDK914406
510k NumberK914406
Device Name:PT II DISTAL CEMENT SPACER
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
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 CodeJDI  
CFR Regulation Number888.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-10-02
Decision Date1991-12-20

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07613327013986 K914406 000
07613327013818 K914406 000
07613327013825 K914406 000
07613327013832 K914406 000
07613327013849 K914406 000
07613327013856 K914406 000
07613327013863 K914406 000
07613327013870 K914406 000
07613327013894 K914406 000
07613327013900 K914406 000
07613327013917 K914406 000
07613327013924 K914406 000
07613327013931 K914406 000
07613327013948 K914406 000
07613327013955 K914406 000
07613327013962 K914406 000
07613327013979 K914406 000
07613327013801 K914406 000

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