NextAR Spine Platform

GUDID 07630345709882

NextAR Spine Solid Drill Ø3,6mm depth 35mm

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 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 ID07630345709882
NIH Device Record Key0f2effa0-7248-4c41-8244-43082fb42c21
Commercial Distribution StatusIn Commercial Distribution
Brand NameNextAR Spine Platform
Version Model Number03.57.10.0064
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 Usefalse
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
GS107630345709882 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[07630345709882]

Moist Heat or Steam Sterilization

[07630345709882]

Moist Heat or Steam Sterilization

[07630345709882]

Moist Heat or Steam Sterilization

[07630345709882]

Moist Heat or Steam Sterilization

[07630345709882]

Moist Heat or Steam Sterilization

[07630345709882]

Moist Heat or Steam Sterilization

[07630345709882]

Moist Heat or Steam Sterilization

[07630345709882]

Moist Heat or Steam Sterilization

[07630345709882]

Moist Heat or Steam Sterilization

[07630345709882]

Moist Heat or Steam Sterilization

[07630345709882]

Moist Heat or Steam Sterilization

[07630345709882]

Moist Heat or Steam Sterilization

[07630345709882]

Moist Heat or Steam Sterilization

[07630345709882]

Moist Heat or Steam Sterilization

[07630345709882]

Moist Heat or Steam Sterilization

[07630345709882]

Moist Heat or Steam Sterilization

[07630345709882]

Moist Heat or Steam Sterilization

[07630345709882]

Moist Heat or Steam Sterilization

[07630345709882]

Moist Heat or Steam Sterilization

[07630345709882]

Moist Heat or Steam Sterilization

[07630345709882]

Moist Heat or Steam Sterilization

[07630345709882]

Moist Heat or Steam Sterilization

[07630345709882]

Moist Heat or Steam Sterilization

[07630345709882]

Moist Heat or Steam Sterilization

[07630345709882]

Moist Heat or Steam Sterilization

[07630345709882]

Moist Heat or Steam Sterilization

[07630345709882]

Moist Heat or Steam Sterilization

[07630345709882]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-12-15
Device Publish Date2021-12-07

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07630971292482NextAR Spine MUST cann Tap Ø10mm undersized 0,5mm
07630971292475NextAR Spine MUST cann Tap Ø9mm undersized 0,5mm
07630971292468NextAR Spine MUST cann Tap Ø8mm undersized 0,5mm
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07630345729255MC Cortical Tap Cannulated 7mm
07630345729248MC Cortical Tap Cannulated 6.5mm
07630345729231MC Cortical Tap Cannulated 6mm
07630345729224MC Cortical Tap Cannulated 5.5mm
07630345729217MC Cortical Tap Cannulated 5mm
07630345729200MC Cortical Tap Cannulated 4.5mm
07630345729194MC Cortical Tap Cannulated 4mm
07630345727497NextAR Spine Reduction Screwdriver Inner Shaft Can
07630345727411Screwdriver Outer Shaft for MUST MC
07630345727404Screwdriver Inner Shaft for MUST MC
07630345727244NextAR Spine Screwdriver T15
07630345727237NextAR Spine Probe curved
07630345727220NextAR Spine Solid Tap Ø10mm
07630345727213NextAR Spine Solid Tap Ø9mm
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