HOWMEDICS DRG FEMORAL COMPONENT

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

HOWMEDICA, INC.

The following data is part of a premarket notification filed by Howmedica, Inc. with the FDA for Howmedics Drg Femoral Component.

Pre-market Notification Details

Device IDK936126
510k NumberK936126
Device Name:HOWMEDICS DRG FEMORAL COMPONENT
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Applicant HOWMEDICA, INC. 359 VETERANS BLVD. Rutherford,  NJ  07070 -2584
ContactRobert E Smith
CorrespondentRobert E Smith
HOWMEDICA, INC. 359 VETERANS BLVD. Rutherford,  NJ  07070 -2584
Product CodeJDI  
CFR Regulation Number888.3350 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-12-23
Decision Date1994-10-20

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