MODIFIED ANATOMIC POROUS REPLACEMENT APR ACETABULA

Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component)

INTERMEDICS ORTHOPEDICS

The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Modified Anatomic Porous Replacement Apr Acetabula.

Pre-market Notification Details

Device IDK850793
510k NumberK850793
Device Name:MODIFIED ANATOMIC POROUS REPLACEMENT APR ACETABULA
ClassificationProsthesis, Hip, Semi-constrained (metal Cemented Acetabular Component)
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 CodeJDL  
CFR Regulation Number888.3320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-02-26
Decision Date1985-05-09

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