APR II NON-POROUS HIP STEM

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 Apr Ii Non-porous Hip Stem.

Pre-market Notification Details

Device IDK913208
510k NumberK913208
Device Name:APR II NON-POROUS HIP STEM
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Applicant INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin,  TX  78752
ContactWebb
CorrespondentWebb
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 Received1991-07-19
Decision Date1991-10-11

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