NextAR TKA Platform

GUDID 07630971281356

NextAR micrometric cutting guide

Medacta International SA

Optical surgical navigation device tracking system
Primary Device ID07630971281356
NIH Device Record Keydcb9cc37-2d43-4d18-988c-5a84d41073c1
Commercial Distribution StatusIn Commercial Distribution
Brand NameNextAR TKA Platform
Version Model Number02.23.10.0010
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
GS107630971281356 [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 Date2020-08-31
Device Publish Date2020-08-21

On-Brand Devices [NextAR TKA Platform ]

07630971281370NextAR micrometric cutting guide cut slot
07630971281363NextAR micrometric cutting guide connection plate
07630971281356NextAR micrometric cutting guide
07630971281349NextAR cut checker femur-tibia
07630971281332NextAR 4in1 holder for GMK Efficiency
07630971281325NextAR trial tibial baseplate holder for GMK Efficiency
07630971281318NextAR curved stylus
07630971281301NextAR straight stylus
07630971281295NextAR modular tracker holder
07630971281288NextAR tracker holder right
07630971281271NextAR tracker holder left
07630971267565NextAR active infrared tracker small (18)
07630971267558NextAR infrared camera
07630345732170Screwdriver Torx T15
07630345732163NextAR drilling guide for sensor holders
07630345732156NextAR sleeve for micrometric cutting guide
07630345732149NextAR Cut checker conical connection
07630345732132NextAR Slot checker conical connection
07630345732125NextAR GMK Eff trial baseplate holder conical conn
07630345732118NextAR GMK Eff 4in1 holder conical conn
07630345732101NextAR large handle conical connection right
07630345732095NextAR large handle conical connection left
07630345732088NextAR small handle conical connection right
07630345732071NextAR small handle conical connection left
07630345732064NextAR curved stylus conical connection
07630345732057NextAR Straight stylus conical connection
07630345732040NextAR small target holder left
07630345732033NextAR small camera holder left
07630345732026NextAR small target holder right
07630345732019NextAR small camera holder right
07630345732002NextAR Micrometric guide small
07630345717962NextAR 2.0 instruments tray
07630345749949NextAR GMK Metal trial basepl holder conical conn
07630345749932NextAR GMK 4in1 slot holder conical conn
07630345775702NextAR Micrometric Guide Shim +4mm
07630345775696NextAR Micrometric Guide Shim +3mm
07630345775689NextAR Micrometric Guide Shim +2mm
07630345775672NextAR Micrometric Guide Shim +1mm
07630345775665NextAR Micrometric Guide Shim 0mm
07630345775658NextAR Micrometric Guide Shim -1mm
07630345775641NextAR Micrometric Guide Shim -2mm
07630345775634NextAR Micrometric Guide Shim -3mm
07630345775627NextAR Micrometric Guide Shim -4mm
07630345775610NextAR Micrometric Guide – Height Adjustment
07630971289215NextAR micrometric cutting guide connection fork
07630971289208NextAR cutting guide GMK efficiency
07630971289192NextAR cut verifier
07630971288829NextAR PSI-free drilling guide tibia
07630971288812NextAR PSI-free drilling guide femur
07630971288805NextAR PSI-free tracker holder right

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