GMK Primary Total Knee System

GUDID 07630030817229

Full-PE UC Tibial Component #3/14

Medacta International SA

Uncoated knee tibia prosthesis, polyethylene
Primary Device ID07630030817229
NIH Device Record Key7b7a6a08-df5f-4226-9d91-fe8fb34a1746
Commercial Distribution StatusIn Commercial Distribution
Brand NameGMK Primary Total Knee System
Version Model Number02.07.0314APUC
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
GS107630030817229 [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 Date2019-12-11
Device Publish Date2014-11-18

On-Brand Devices [GMK Primary Total Knee System]

07630030822667Primary extension stem Ø11mm, 65mm
07630030822643Primary Extension Stem Ø 11, 30 mm
07630030821059Femur Narrow cemented PS Right, size 7
07630030821042Femur Narrow cemented PS Left, size 7
07630030821035Femur Narrow cemented PS Right, size 6
07630030821028Femur Narrow cemented PS Left, size 6
07630030821011Femur Narrow cemented PS Right, size 5
07630030821004Femur Narrow cemented PS Left, size 5
07630030820991Femur Narrow cemented PS Right, size 4
07630030820984Femur Narrow cemented PS Left, size 4
07630030820977Femur Narrow cemented PS Right, size 3
07630030820960Femur Narrow cemented PS Left, size 3
07630030820953Femur Narrow cemented PS Right, size 2
07630030820946Femur Narrow cemented PS Left, size 2
07630030820939Femur Narrow cemented PS Right, size 1
07630030820922Femur Narrow cemented PS Left, size 1
07630030820915Femur PS cemented Right, size 7
07630030820908Femur PS cemented Left, size 7
07630030820892Femur PS cemented right, size 6
07630030820885Femur PS cemented left, size 6
07630030820878Femur PS cemented right, size 5
07630030820861Femur PS cemented left, size 5
07630030820854Femur PS cemented right, size 4
07630030820847Femur PS cemented left, size 4
07630030820830Femur PS cemented right, size 3
07630030820823Femur PS cemented left, size 3
07630030820816Femur PS cemented right, size 2
07630030820809Femur PS cemented left, size 2
07630030820793Femur PS cemented right, size 1
07630030820786Femur PS cemented left, size 1
07630030820779Femur PS cemented Right, size 0
07630030820762Femur PS cemented Left, size 0
07630030820427Femur Narrow cemented STD Right, size 7
07630030820410Femur Narrow cemented STD Left, size 7
07630030820403Femur Narrow cemented STD Right, size 6
07630030820397Femur Narrow cemented STD Left, size 6
07630030820380Femur Narrow cemented STD Right, size 5
07630030820373Femur Narrow cemented STD Left, size 5
07630030820366Femur Narrow cemented STD Right, size 4
07630030820359Femur Narrow cemented STD Left, size 4
07630030820342Femur Narrow cemented STD Right, size 3
07630030820335Femur Narrow cemented STD Left, size 3
07630030820328Femur Narrow cemented STD Right, size 2
07630030820311Femur Narrow cemented STD Left, size 2
07630030820304Femur Narrow cemented STD Right, size 1
07630030820298Femur Narrow cemented STD Left, size 1
07630030820281Femur STD cemented Right, size 7
07630030820274Femur STD cemented Left, size 7
07630030820267Femur STD cemented right, size 6
07630030820250Femur STD cemented left, size 6

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