GMK RESUFACING PATELLA SIZE 4

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

MEDACTA INTERNATIONAL

The following data is part of a premarket notification filed by Medacta International with the FDA for Gmk Resufacing Patella Size 4.

Pre-market Notification Details

Device IDK113571
510k NumberK113571
Device Name:GMK RESUFACING PATELLA SIZE 4
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant MEDACTA INTERNATIONAL 4725 Calle Quetzal, Unit B Camarillo,  CA  93012
ContactAdam Gross
CorrespondentAdam Gross
MEDACTA INTERNATIONAL 4725 Calle Quetzal, Unit B Camarillo,  CA  93012
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-12-02
Decision Date2012-01-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07630030815775 K113571 000

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