KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM, POROUS

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

KIRSCHNER MEDICAL CORP.

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

Pre-market Notification Details

Device IDK895962
510k NumberK895962
Device Name:KIRSCHNER PERFORMANCE TOTAL KNEE SYSTEM, POROUS
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/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 CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent For Some Indications (SN)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-10-11
Decision Date1990-01-09

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