MODULAR UNIPOLAR 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 Modular Unipolar System.

Pre-market Notification Details

Device IDK902365
510k NumberK902365
Device Name:MODULAR UNIPOLAR SYSTEM
ClassificationProsthesis, Hip, Hemi-, Femoral, Metal
Applicant HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford,  NJ  07070
ContactMary C Spicer
CorrespondentMary C Spicer
HOWMEDICA CORP. 359 VETERANS BLVD. Rutherford,  NJ  07070
Product CodeKWL  
CFR Regulation Number888.3360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-05-30
Decision Date1991-01-11

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07613327013399 K902365 000
07613327013382 K902365 000
07613327013375 K902365 000
07613327013368 K902365 000

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