MyKnee R Pin Positioners

GUDID 07630971283619

MyKnee R TibPinPositioner-CT-GMK-R-#4

Medacta International SA

Orthopaedic prosthesis implantation instrument, single-use
Primary Device ID07630971283619
NIH Device Record Keyda69cf31-f714-464e-80c4-229ffbd5d9f2
Commercial Distribution StatusIn Commercial Distribution
Brand NameMyKnee R Pin Positioners
Version Model Number17.1044
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107630971283619 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

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

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07630971283619]

Moist Heat or Steam Sterilization


[07630971283619]

Moist Heat or Steam Sterilization


[07630971283619]

Moist Heat or Steam Sterilization


[07630971283619]

Moist Heat or Steam Sterilization


[07630971283619]

Moist Heat or Steam Sterilization


[07630971283619]

Moist Heat or Steam Sterilization


[07630971283619]

Moist Heat or Steam Sterilization


[07630971283619]

Moist Heat or Steam Sterilization


[07630971283619]

Moist Heat or Steam Sterilization


[07630971283619]

Moist Heat or Steam Sterilization


[07630971283619]

Moist Heat or Steam Sterilization


[07630971283619]

Moist Heat or Steam Sterilization


[07630971283619]

Moist Heat or Steam Sterilization


[07630971283619]

Moist Heat or Steam Sterilization


[07630971283619]

Moist Heat or Steam Sterilization


[07630971283619]

Moist Heat or Steam Sterilization


[07630971283619]

Moist Heat or Steam Sterilization


[07630971283619]

Moist Heat or Steam Sterilization


[07630971283619]

Moist Heat or Steam Sterilization


[07630971283619]

Moist Heat or Steam Sterilization


[07630971283619]

Moist Heat or Steam Sterilization


[07630971283619]

Moist Heat or Steam Sterilization


[07630971283619]

Moist Heat or Steam Sterilization


[07630971283619]

Moist Heat or Steam Sterilization


[07630971283619]

Moist Heat or Steam Sterilization


[07630971283619]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-05-16
Device Publish Date2022-05-06

On-Brand Devices [MyKnee R Pin Positioners]

07630971283664MyKnee R TibPinPositioner-CT-GMK-R-#6 ST
07630971283657MyKnee R TibPinPositioner-CT-GMK-R-#6
07630971283640MyKnee R TibPinPositioner-CT-GMK-R-#5 ST
07630971283633MyKnee R TibPinPositioner-CT-GMK-R-#5
07630971283626MyKnee R TibPinPositioner-CT-GMK-R-#4 ST
07630971283619MyKnee R TibPinPositioner-CT-GMK-R-#4
07630971283602MyKnee R TibPinPositioner-CT-GMK-R-#3 ST
07630971283596MyKnee R TibPinPositioner-CT-GMK-R-#3
07630971283589MyKnee R TibPinPositioner-CT-GMK-R-#2 ST
07630971283572MyKnee R TibPinPositioner-CT-GMK-R-#2
07630971283565MyKnee R TibPinPositioner-CT-GMK-R-#1 ST
07630971283558MyKnee R TibPinPositioner-CT-GMK-R-#1
07630971283541MyKnee R TibPinPositioner-CT-GMK-L-#6 ST
07630971283534MyKnee R TibPinPositioner-CT-GMK-L-#6
07630971283527MyKnee R TibPinPositioner-CT-GMK-L-#5 ST
07630971283510MyKnee R TibPinPositioner-CT-GMK-L-#5
07630971283503MyKnee R TibPinPositioner-CT-GMK-L-#4 ST
07630971283497MyKnee R TibPinPositioner-CT-GMK-L-#4
07630971283480MyKnee R TibPinPositioner-CT-GMK-L-#3 ST
07630971283473MyKnee R TibPinPositioner-CT-GMK-L-#3
07630971283466MyKnee R TibPinPositioner-CT-GMK-L-#2 ST
07630971283459MyKnee R TibPinPositioner-CT-GMK-L-#2
07630971283442MyKnee R TibPinPositioner-CT-GMK-L-#1 ST
07630971283435MyKnee R TibPinPositioner-CT-GMK-L-#1
07630971283428MyKnee R FemPinPositioner-CT-GMK-R-#6 ST
07630971283411MyKnee R FemPinPositioner-CT-GMK-R-#6
07630971283404MyKnee R FemPinPositioner-CT-GMK-R-#5 ST
07630971283398MyKnee R FemPinPositioner-CT-GMK-R-#5
07630971283381MyKnee R FemPinPositioner-CT-GMK-R-#4 ST
07630971283374MyKnee R FemPinPositioner-CT-GMK-R-#4
07630971283367MyKnee R FemPinPositioner-CT-GMK-R-#3 ST
07630971283350MyKnee R FemPinPositioner-CT-GMK-R-#3
07630971283343MyKnee R FemPinPositioner-CT-GMK-R-#2 ST
07630971283336MyKnee R FemPinPositioner-CT-GMK-R-#2
07630971283329MyKnee R FemPinPositioner-CT-GMK-R-#1 ST
07630971283312MyKnee R FemPinPositioner-CT-GMK-R-#1
07630971283305MyKnee R FemPinPositioner-CT-GMK-L-#6 ST
07630971283299MyKnee R FemPinPositioner-CT-GMK-L-#6
07630971283282MyKnee R FemPinPositioner-CT-GMK-L-#5 ST
07630971283275MyKnee R FemPinPositioner-CT-GMK-L-#5
07630971283268MyKnee R FemPinPositioner-CT-GMK-L-#4 ST
07630971283251MyKnee R FemPinPositioner-CT-GMK-L-#4
07630971283244MyKnee R FemPinPositioner-CT-GMK-L-#3 ST
07630971283237MyKnee R FemPinPositioner-CT-GMK-L-#3
07630971283220MyKnee R FemPinPositioner-CT-GMK-L-#2 ST
07630971283213MyKnee R FemPinPositioner-CT-GMK-L-#2
07630971283206MyKnee R FemPinPositioner-CT-GMK-L-#1 ST
07630971283190MyKnee R FemPinPositioner-CT-GMK-L-#1

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