MUELLER TYPE FEMORAL STEM

Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

OSTEO TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Osteo Technology, Inc. with the FDA for Mueller Type Femoral Stem.

Pre-market Notification Details

Device IDK922864
510k NumberK922864
Device Name:MUELLER TYPE FEMORAL STEM
ClassificationProsthesis, Hip, Semi-constrained, Metal/polymer, Cemented
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 CodeJDI  
CFR Regulation Number888.3350 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-06-04
Decision Date1993-02-12

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