DRG CEMETED 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 Drg Cemeted Stem.

Pre-market Notification Details

Device IDK920003
510k NumberK920003
Device Name:DRG CEMETED STEM
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
Applicant 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 Received1992-01-02
Decision Date1992-03-13

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