GT HIP PROSTHESIS FEMORAL COMPONENT

Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

INTERMEDICS ORTHOPEDICS

The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Gt Hip Prosthesis Femoral Component.

Pre-market Notification Details

Device IDK853169
510k NumberK853169
Device Name:GT HIP PROSTHESIS FEMORAL COMPONENT
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Applicant INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin,  TX  78752
ContactThomas L Craig
CorrespondentThomas L Craig
INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin,  TX  78752
Product CodeJDI  
CFR Regulation Number888.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-07-30
Decision Date1985-10-29

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