PRECISION HIP LONG STEM FEMORAL COMPONENT SYSTEM

Prosthesis, Hip, Femoral Component, Cemented, Metal

HOWMEDICA CORP.

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

Pre-market Notification Details

Device IDK873089
510k NumberK873089
Device Name:PRECISION HIP LONG STEM FEMORAL COMPONENT SYSTEM
ClassificationProsthesis, Hip, Femoral Component, Cemented, Metal
Applicant HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford,  NJ  07070
ContactRobert E Smith
CorrespondentRobert E Smith
HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford,  NJ  07070
Product CodeJDG  
CFR Regulation Number888.3360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-08-05
Decision Date1987-09-16

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