GMK-Revision/Hinge Total Knee System

GUDID 07630030877032

Screwed Tibial Augmentation # 5/15 mm (LM/RL)

Medacta International SA

Knee arthroplasty wedge
Primary Device ID07630030877032
NIH Device Record Key491458cc-4a33-4126-8bc2-3baae579d5cc
Commercial Distribution StatusIn Commercial Distribution
Brand NameGMK-Revision/Hinge Total Knee System
Version Model Number02.09.TA515LMRL
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
GS107630030877032 [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 Number3
Public Version Date2018-07-06
Device Publish Date2017-11-10

On-Brand Devices [GMK-Revision/Hinge Total Knee System]

07630030888977Femoral Augmentation distal # 6/20 mm
07630030888960Femoral Augmentation distal # 6/16 mm
07630030888953Femoral Augmentation distal # 5/20 mm
07630030888946Femoral Augmentation distal # 5/16 mm
07630030888939Femoral Augmentation distal # 4/20 mm
07630030888922Femoral Augmentation distal # 4/16 mm
07630030888915Femoral Augmentation distal # 3/20 mm
07630030888908Femoral Augmentation distal # 3/16 mm
07630030888892Femoral Augmentation distal # 2/20 mm
07630030888885Femoral Augmentation distal # 2/16 mm
07630030888878Femoral Augmentation distal # 1/20 mm
07630030888861Femoral Augmentation distal # 1/16 mm
07630030885501Femoral Augmentation distal # 6/12 mm
07630030885495Femoral Augmentation distal # 5/12 mm
07630030885488Femoral Augmentation distal # 4/12 mm
07630030885129Femoral Augmentation distal # 3/12 mm
07630030879524UC Fixed tibial insert #6/26 mm
07630030879517UC Fixed tibial insert #6/23 mm
07630030879500UC Fixed tibial insert #6/20 mm
07630030879494UC Fixed tibial insert #6/17 mm
07630030879487UC Fixed tibial insert #6/14 mm
07630030879470UC Fixed tibial insert #6/12 mm
07630030879456UC Fixed tibial insert #5/26 mm
07630030879449UC Fixed tibial insert #5/23 mm
07630030879432UC Fixed tibial insert #5/20 mm
07630030879425UC Fixed tibial insert #5/17 mm
07630030879418UC Fixed tibial insert #5/14 mm
07630030879401UC Fixed tibial insert #5/12 mm
07630030879388UC Fixed tibial insert #4/26 mm
07630030879371UC Fixed tibial insert #4/23 mm
07630030879364UC Fixed tibial insert #4/20 mm
07630030879357UC Fixed tibial insert #4/17 mm
07630030879340UC Fixed tibial insert #4/14 mm
07630030879333UC Fixed tibial insert #4/12 mm
07630030879319UC Fixed tibial insert #3/26 mm
07630030879302UC Fixed tibial insert #3/23 mm
07630030879296UC Fixed tibial insert #3/20 mm
07630030879289UC Fixed tibial insert #3/17 mm
07630030879272UC Fixed tibial insert #3/14 mm
07630030879265UC Fixed tibial insert #3/12 mm
07630030879241UC Fixed tibial insert #2/26 mm
07630030879234UC Fixed tibial insert #2/23 mm
07630030879227UC Fixed tibial insert #2/20 mm
07630030879210UC Fixed tibial insert #2/17 mm
07630030879203UC Fixed tibial insert #2/14 mm
07630030879197UC Fixed tibial insert #2/12 mm
07630030879173UC Fixed tibial insert #1/26 mm
07630030879166UC Fixed tibial insert #1/23 mm
07630030879159UC Fixed tibial insert #1/20 mm
07630030879142UC Fixed tibial insert #1/17 mm

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