APOLLO(TM) HIP SYST-STRAIGHT STEM/ALL-POLY ACET COMP

Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

INTERMEDICS ORTHOPEDICS

The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Apollo(tm) Hip Syst-straight Stem/all-poly Acet Comp.

Pre-market Notification Details

Device IDK933203
510k NumberK933203
Device Name:APOLLO(TM) HIP SYST-STRAIGHT STEM/ALL-POLY ACET COMP
ClassificationProsthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
Applicant INTERMEDICS ORTHOPEDICS 1300-C EAST ANDERSON LN. Austin,  TX  78752
ContactJoann Ringer
CorrespondentJoann Ringer
INTERMEDICS ORTHOPEDICS 1300-C EAST ANDERSON LN. Austin,  TX  78752
Product CodeLZO  
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-07-01
Decision Date1994-04-19

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