HIP FRACTURE STEM SYSTEM

Prosthesis, Hip, Hemi-, Femoral, Metal

HOWMEDICA CORP.

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

Pre-market Notification Details

Device IDK883179
510k NumberK883179
Device Name:HIP FRACTURE STEM SYSTEM
ClassificationProsthesis, Hip, Hemi-, Femoral, Metal
Applicant HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford,  NJ  07070
ContactRobert Smith
CorrespondentRobert Smith
HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford,  NJ  07070
Product CodeKWL  
CFR Regulation Number888.3360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-07-27
Decision Date1988-09-22

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