SCORPIO-FLEX POSTERIOR STABILIZED TIBIAL INSERT COMPONENTS

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

HOWMEDICA OSTEONICS CORP

The following data is part of a premarket notification filed by Howmedica Osteonics Corp with the FDA for Scorpio-flex Posterior Stabilized Tibial Insert Components.

Pre-market Notification Details

Device IDK041591
510k NumberK041591
Device Name:SCORPIO-FLEX POSTERIOR STABILIZED TIBIAL INSERT COMPONENTS
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah,  NJ  07430
ContactKaren Ariemma
CorrespondentKaren Ariemma
HOWMEDICA OSTEONICS CORP 325 CORPORATE DR. Mahwah,  NJ  07430
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-06-14
Decision Date2004-09-23
Summary:summary

NIH GUDID Devices

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