THOMPSON TYPE HIP PROTHESIS

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

OSTEO TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Osteo Technology, Inc. with the FDA for Thompson Type Hip Prothesis.

Pre-market Notification Details

Device IDK922868
510k NumberK922868
Device Name:THOMPSON TYPE HIP PROTHESIS
ClassificationProsthesis, Hip, Semi-constrained (metal Uncemented Acetabular Component)
Applicant OSTEO TECHNOLOGY, INC. 10 WEST AYLESBURY RD. Timonium,  MD  21093
ContactSam Son
CorrespondentSam Son
OSTEO TECHNOLOGY, INC. 10 WEST AYLESBURY RD. Timonium,  MD  21093
Product CodeKWA  
CFR Regulation Number888.3330 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-06-04
Decision Date1993-02-12

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