NextAR Knee Platform

GUDID 07630345731654

MyKnee NextAR TibPinPositioner_Ass-CT-GMK-LM-sterile

Medacta International SA

Orthopaedic prosthesis implantation instrument, single-use
Primary Device ID07630345731654
NIH Device Record Keyb968e163-5752-4e8f-aff5-6cae124bf6d9
Commercial Distribution StatusIn Commercial Distribution
Brand NameNextAR Knee Platform
Version Model Number15.8010S
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
GS107630345731654 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-22
Device Publish Date2022-03-14

On-Brand Devices [NextAR Knee Platform ]

07630345731807MyKnee NextAR FemPinPositioner_Ass-CT-GMK-RM-sterile
07630345731791MyKnee NextAR FemPinPositioner_Ass-CT-GMK-RM
07630345731784MyKnee NextAR FemPinPositioner_Ass-CT-GMK-LM-sterile
07630345731777MyKnee NextAR FemPinPositioner_Ass-CT-GMK-LM
07630345731678MyKnee NextAR TibPinPositioner_Ass-CT-GMK-RM-sterile
07630345731661MyKnee NextAR TibPinPositioner_Ass-CT-GMK-RM
07630345731654MyKnee NextAR TibPinPositioner_Ass-CT-GMK-LM-sterile
07630345731647MyKnee NextAR TibPinPositioner_Ass-CT-GMK-LM

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