HOWMEDICA OSTEONICS FEMORAL HEADS

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

HOWMEDICA OSTEONICS CORP.

The following data is part of a premarket notification filed by Howmedica Osteonics Corp. with the FDA for Howmedica Osteonics Femoral Heads.

Pre-market Notification Details

Device IDK993601
510k NumberK993601
Device Name:HOWMEDICA OSTEONICS FEMORAL HEADS
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Uncemented
Applicant HOWMEDICA OSTEONICS CORP. 359 VETERANS BLVD. Rutherford,  NJ  07070 -2584
ContactNancy J Rieder
CorrespondentNancy J Rieder
HOWMEDICA OSTEONICS CORP. 359 VETERANS BLVD. Rutherford,  NJ  07070 -2584
Product CodeLWJ  
CFR Regulation Number888.3360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-10-25
Decision Date1999-11-16
Summary:summary

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