PREMIER-TOTAL(TM) HIP WITH CALCITITE(R) COATING

Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate

INTERMEDICS ORTHOPEDICS

The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Premier-total(tm) Hip With Calcitite(r) Coating.

Pre-market Notification Details

Device IDK910755
510k NumberK910755
Device Name:PREMIER-TOTAL(TM) HIP WITH CALCITITE(R) COATING
ClassificationProsthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
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 CodeMEH  
CFR Regulation Number888.3353 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-02-15
Decision Date1991-03-26

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