HOWMEDICA ASYMMETRIC STEM FEMORAL COMPONENT

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

HOWMEDICA CORP.

The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for Howmedica Asymmetric Stem Femoral Component.

Pre-market Notification Details

Device IDK955871
510k NumberK955871
Device Name:HOWMEDICA ASYMMETRIC STEM FEMORAL COMPONENT
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
Applicant HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford,  NJ  07070
ContactJohn Dichiara
CorrespondentJohn Dichiara
HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford,  NJ  07070
Product CodeLPH  
CFR Regulation Number888.3358 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-12-26
Decision Date1996-03-22
Summary:summary

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