NextAR TKA Platform

GUDID 07630345732163

NextAR drilling guide for sensor holders

Medacta International SA

Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system
Primary Device ID07630345732163
NIH Device Record Keyc3b5a0e4-c20d-4ae3-8a9e-d5d1702eeaa6
Commercial Distribution StatusIn Commercial Distribution
Brand NameNextAR TKA Platform
Version Model Number02.23.10.0042
Company DUNS488227125
Company NameMedacta International SA
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
GS107630345732163 [Primary]

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 Date2021-07-22
Device Publish Date2021-07-14

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

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.