PREMISE CEMENTED FEMORAL STEM, ADDITION STYLE

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

HOWMEDICA CORP.

The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Premise Cemented Femoral Stem, Addition Style.

Pre-market Notification Details

Device IDK933875
510k NumberK933875
Device Name:PREMISE CEMENTED FEMORAL STEM, ADDITION STYLE
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Applicant HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford,  NJ  07070
ContactRobert E Smith
CorrespondentRobert E Smith
HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford,  NJ  07070
Product CodeJDI  
CFR Regulation Number888.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-08-09
Decision Date1994-03-01

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