IOI BIPOLAR PROSTHESIS

Prosthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented

INTERMEDICS ORTHOPEDICS

The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Ioi Bipolar Prosthesis.

Pre-market Notification Details

Device IDK873815
510k NumberK873815
Device Name:IOI BIPOLAR PROSTHESIS
ClassificationProsthesis, Hip, Hemi-, Femoral, Metal/polymer, Cemented Or Uncemented
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 CodeKWY  
CFR Regulation Number888.3390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-09-21
Decision Date1987-10-28

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.