KIRSCHNER UNICONDYLAR KNEE SYSTEM

Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer

KIRSCHNER MEDICAL CORP.

The following data is part of a premarket notification filed by Kirschner Medical Corp. with the FDA for Kirschner Unicondylar Knee System.

Pre-market Notification Details

Device IDK873970
510k NumberK873970
Device Name:KIRSCHNER UNICONDYLAR KNEE SYSTEM
ClassificationProsthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Applicant KIRSCHNER MEDICAL CORP. 9690 DEERECO ROADD Timonium,  MD  21093
ContactSam Son
CorrespondentSam Son
KIRSCHNER MEDICAL CORP. 9690 DEERECO ROADD Timonium,  MD  21093
Product CodeHSX  
CFR Regulation Number888.3520 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-09-29
Decision Date1987-12-31

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