INTERMEDICS APR(TM) II FEMORAL COMPONENT

Mesh, Surgical, Acetabular, Hip, Prosthesis

INTERMEDICS ORTHOPEDICS

The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Intermedics Apr(tm) Ii Femoral Component.

Pre-market Notification Details

Device IDK890450
510k NumberK890450
Device Name:INTERMEDICS APR(TM) II FEMORAL COMPONENT
ClassificationMesh, Surgical, Acetabular, Hip, Prosthesis
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 CodeJDJ  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-01-30
Decision Date1989-08-09

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