TOTAL CONDYLAT TYPE KNEE SYSTEM

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

OSTEO TECHNOLOGY, INC.

The following data is part of a premarket notification filed by Osteo Technology, Inc. with the FDA for Total Condylat Type Knee System.

Pre-market Notification Details

Device IDK922869
510k NumberK922869
Device Name:TOTAL CONDYLAT TYPE KNEE SYSTEM
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
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 CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-06-04
Decision Date1993-07-13

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