MODUILAR UNIPOLAR

Prosthesis, Hip, Femoral, Resurfacing

INTERMEDICS ORTHOPEDICS

The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Moduilar Unipolar.

Pre-market Notification Details

Device IDK950998
510k NumberK950998
Device Name:MODUILAR UNIPOLAR
ClassificationProsthesis, Hip, Femoral, Resurfacing
Applicant INTERMEDICS ORTHOPEDICS 1300-C EAST ANDERSON LN. Austin,  TX  78752
ContactJoann Ringer-kuhne
CorrespondentJoann Ringer-kuhne
INTERMEDICS ORTHOPEDICS 1300-C EAST ANDERSON LN. Austin,  TX  78752
Product CodeKXA  
CFR Regulation Number888.3400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-03-03
Decision Date1995-04-13

NIH GUDID Devices

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