GMK SHORT STEM

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 Short Stem.

Pre-market Notification Details

Device IDK133630
510k NumberK133630
Device Name:GMK SHORT STEM
ClassificationProsthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
Applicant MEDACTA INTERNATIONAL 1556 W CARROLL AVE Chicago,  IL  60607
ContactAdam Gross
CorrespondentAdam Gross
MEDACTA INTERNATIONAL 1556 W CARROLL AVE Chicago,  IL  60607
Product CodeJWH  
CFR Regulation Number888.3560 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-11-26
Decision Date2013-12-20
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07630030822643 K133630 000

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