Evolis Total Knee System

GUDID 07630030845574

Standard PE insert 13mm, size 6

Medacta International SA

Tibial insert
Primary Device ID07630030845574
NIH Device Record Key17c203d2-6b95-4ea3-ba68-e313d9d1b430
Commercial Distribution StatusIn Commercial Distribution
Brand NameEvolis Total Knee System
Version Model Number3040.0613
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
GS107630030845574 [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 Date2014-11-18

On-Brand Devices [Evolis Total Knee System]

07630030846649Cancellous Bone Screw Ø 6,5 / L 45mm
07630030846632Cancellous Bone Screw Ø 6,5 / L 40mm
07630030846625Cancellous Bone Screw Ø 6,5 / L 35mm
07630030846618Cancellous Bone Screw Ø 6,5 / L 30mm
07630030846601Cancellous Bone Screw Ø 6,5 / L 25mm
07630030846595Cancellous Bone Screw Ø 6,5 / L 20mm
07630030846564Resurfacing Patella 39mm
07630030846557Resurfacing Patella 36mm
07630030846540Resurfacing Patella 33mm
07630030846533Resurfacing Patella 30mm
07630030846526Inset Patella 28mm
07630030846519Inset Patella 24mm
07630030846502Inset Patella 20mm
07630030846496UC Flex PE insert 19mm, size 6
07630030846489UC Flex PE insert 16mm, size 6
07630030846472UC Flex PE insert 13mm, size 6
07630030846465UC Flex PE insert 11mm, size 6
07630030846458UC Flex PE insert 9mm, size 6
07630030846441UC Flex PE insert 19mm, size 5
07630030846434UC Flex PE insert 16mm, size 5
07630030846427UC Flex PE insert 13mm, size 5
07630030846410UC Flex PE insert 11mm, size 5
07630030846403UC Flex PE insert 9mm, size 5
07630030846397UC Flex PE insert 19mm, size 4
07630030846380UC Flex PE insert 16mm, size 4
07630030846373UC Flex PE insert 13mm, size 4
07630030846366UC Flex PE insert 11mm, size 4
07630030846359UC Flex PE insert 9mm, size 4
07630030846342UC Flex PE insert 19mm, size 3
07630030846335UC Flex PE insert 16mm, size 3
07630030846328UC Flex PE insert 13mm, size 3
07630030846311UC Flex PE insert 11mm, size 3
07630030846304UC Flex PE insert 9mm, size 3
07630030846298UC Flex PE insert 19mm, size 2
07630030846281UC Flex PE insert 16mm, size 2
07630030846274UC Flex PE insert 13mm, size 2
07630030846267UC Flex PE insert 11mm, size 2
07630030846250UC Flex PE insert 9mm, size 2
07630030846243UC Flex PE insert 19mm, size 1
07630030846236UC Flex PE insert 16mm, size 1
07630030846229UC Flex PE insert 13mm, size 1
07630030846212UC Flex PE insert 11mm, size 1
07630030846205UC Flex PE insert 9mm, size 1
07630030845895Postero-Sabilized PE insert 19mm, size 6
07630030845888Postero-Sabilized PE insert 16mm, size 6
07630030845871Postero-Sabilized PE insert 13mm, size 6
07630030845864Postero-Sabilized PE insert 11mm, size 6
07630030845857Postero-Sabilized PE insert 9mm, size 6
07630030845840Postero-Sabilized PE insert 19mm, size 5
07630030845833Postero-Sabilized PE insert 16mm, size 5
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