GMK Revision Total Knee System

GUDID 07630030822858

Fluted Extension stem Ø10mm, 105mm

Medacta International SA

Knee femur stem prosthesis
Primary Device ID07630030822858
NIH Device Record Keyf690e675-287f-4eea-a96a-1dc2d8eb3613
Commercial Distribution StatusIn Commercial Distribution
Brand NameGMK Revision Total Knee System
Version Model Number02.07.FCL10105
Company DUNS488227125
Company NameMedacta International SA
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107630030822858 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-04-20
Device Publish Date2014-11-18

On-Brand Devices [GMK Revision Total Knee System]

07630030823190Cemented Extension stem Ø16mm, 105mm
07630030823183Cemented Extension stem Ø16mm, 65mm
07630030823176Cemented Extension stem Ø13mm, 105mm
07630030823169Cemented Extension stem Ø13mm, 65mm
07630030823152Cemented Extension stem Ø11mm, 105mm
07630030823145Cemented Extension stem Ø11mm, 65mm
07630030823138Fluted Extension stem Ø22mm, 150mm
07630030823121Fluted Extension stem Ø22mm, 105mm
07630030823114Fluted Extension stem Ø22mm, 65mm
07630030823107Fluted Extension stem Ø20mm, 150mm
07630030823091Fluted Extension stem Ø20mm, 105mm
07630030823084Fluted Extension stem Ø20mm, 65mm
07630030823077Fluted Extension stem Ø18mm, 150mm
07630030823060Fluted Extension stem Ø18mm, 105mm
07630030823053Fluted Extension stem Ø18mm, 65mm
07630030823046Fluted Extension stem Ø16mm, 150mm
07630030823039Fluted Extension stem Ø16mm, 105mm
07630030823022Fluted Extension stem Ø16mm, 65mm
07630030823015Fluted Extension stem Ø15mm, 150mm
07630030823008Fluted Extension stem Ø15mm, 105mm
07630030822995Fluted Extension stem Ø15mm, 65mm
07630030822988Fluted Extension stem Ø14mm, 150mm
07630030822971Fluted Extension stem Ø14mm, 105mm
07630030822964Fluted Extension stem Ø14mm, 65mm
07630030822957Fluted Extension stem Ø13mm, 150mm
07630030822940Fluted Extension stem Ø13mm, 105mm
07630030822933Fluted Extension stem Ø13mm, 65mm
07630030822926Fluted Extension stem Ø12mm, 150mm
07630030822919Fluted Extension stem Ø12mm, 105mm
07630030822902Fluted Extension stem Ø12mm, 65mm
07630030822896Fluted Extension stem Ø11mm, 150mm
07630030822889Fluted Extension stem Ø11mm, 105mm
07630030822872Fluted Extension stem Ø11mm, 65mm
07630030822865Fluted Extension stem Ø10mm, 150mm
07630030822858Fluted Extension stem Ø10mm, 105mm
07630030822841Fluted Extension stem Ø10mm, 65mm
07630030822803Extension stem Ø22mm, 150mm
07630030822797Extension stem Ø22mm, 105mm
07630030822780Extension stem Ø22mm, 65mm
07630030822773Extension stem Ø19mm, 150mm
07630030822766Extension stem Ø19mm, 105mm
07630030822759Extension stem Ø19mm, 65mm
07630030822742Extension stem Ø16mm, 150mm
07630030822735Extension stem Ø16mm, 105mm
07630030822728Extension stem Ø16mm, 65mm
07630030822711Extension stem Ø13mm, 150mm
07630030822704Extension stem Ø13mm, 105mm
07630030822698Extension stem Ø13mm, 65mm
07630030822681Extension stem Ø11mm, 150mm
07630030822674Extension stem Ø11mm, 105mm

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.