NextAR Spine Platform

GUDID 07630345710178

Sterile NextAR Spine Solid Drill Ø3,6mm depth 40mm

Medacta International SA

Optical surgical navigation device tracking system
Primary Device ID07630345710178
NIH Device Record Key3c73383e-2345-47f2-903d-8d250bba6b4a
Commercial Distribution StatusIn Commercial Distribution
Brand NameNextAR Spine Platform
Version Model Number03.57.10.0093
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
GS107630345710178 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OLOOrthopedic Stereotaxic Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

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

On-Brand Devices [NextAR Spine Platform ]

07630971299719NextAr Spine Target Large
07630971293199NextAR Spine Camera Adapter
07630971292437NextAR Spine MUST cann Tap Ø5mm undersized 0,5mm
07630971292413NextAR Spine Needle for Awl
07630971292390NextAR Spine MUST cann Tap Ø4,5mm undersized 0,3mm
07630971292383NextAR Spine Screwdriver
07630971292376NextAR Spine Camera Adapter for Screwdriver & Tap
07630971292369NextAR Spine Pointer
07630971292352NextAR Spine Awl
07630971292338Sterile NextAR Spine Fiducial
07630345727121NextAR Spine Probe Straight
07630345727114NextAR Spine Drill Guide Handle
07630345727107NextAR Spine Drill Guide Adapter
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
07630971292451NextAR Spine MUST cann Tap Ø7mm undersized 0,5mm
07630971292444NextAR Spine MUST cann Tap Ø6mm undersized 0,5mm
07630345729279NextAR Spine MIS screwdriver for MUST LT 25mm
07630345729262NextAR Spine MIS screwdriver for MUST LT 15mm
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
07630345727206NextAR Spine Solid Tap Ø8mm
07630345727190NextAR Spine Solid Tap Ø7mm
07630345727183NextAR Spine Solid Solid Ø6mm
07630345727176NextAR Spine Solid Tap Ø5mm
07630345727169NextAR Spine Solid Tap Ø4,5mm
07630345710277NextAR Spine Long Confidence Point
07630345710260NextAR Spine Confidence Point
07630345710253NextAR Spine Drill Guide Ø3,6
07630345710246NextAR Spine Drill Guide Ø3,2
07630345710239NextAR Spine Drill Guide Ø2,7
07630345710222NextAR Spine Drill Guide Ø2,4
07630345710215NextAR Spine Drill Guide Ø1,5
07630345710208NextAR Spine Drill Guide Ø1,4
07630345729125NextAR Spine tap aggressive undersize Ø6
07630345729118NextAR Spine tap aggressive undersize Ø5
07630345729101NextAR Spine tap aggressive undersize Ø4.5
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