PSK FEMORAL AND TIBIAL INSERT COMPONENT

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

ORTHOMET, INC.

The following data is part of a premarket notification filed by Orthomet, Inc. with the FDA for Psk Femoral And Tibial Insert Component.

Pre-market Notification Details

Device IDK920426
510k NumberK920426
Device Name:PSK FEMORAL AND TIBIAL INSERT COMPONENT
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant ORTHOMET, INC. 6301 CECILIA CIRCLE Minneapolis,  MN  55439 -2713
ContactDennis H Crane
CorrespondentDennis H Crane
ORTHOMET, INC. 6301 CECILIA CIRCLE Minneapolis,  MN  55439 -2713
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-02-03
Decision Date1992-08-03

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