NextAR Spine Platform

GUDID 07630345727503

NextAR Spine Reduction Screwdriver Inner Shaft Soli

Medacta International SA

Optical surgical navigation device tracking system

• Primary Device ID: 07630345727503
• NIH Device Record Key: 43150ae8-8569-4b00-83cc-a8731b99e93c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NextAR Spine Platform
• Version Model Number: 03.57.10.0141
• Company DUNS: 488227125
• Company Name: Medacta International SA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630345727503 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210859

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[07630345727503]

Moist Heat or Steam Sterilization

[07630345727503]

Moist Heat or Steam Sterilization

[07630345727503]

Moist Heat or Steam Sterilization

[07630345727503]

Moist Heat or Steam Sterilization

[07630345727503]

Moist Heat or Steam Sterilization

[07630345727503]

Moist Heat or Steam Sterilization

[07630345727503]

Moist Heat or Steam Sterilization

[07630345727503]

Moist Heat or Steam Sterilization

[07630345727503]

Moist Heat or Steam Sterilization

[07630345727503]

Moist Heat or Steam Sterilization

[07630345727503]

Moist Heat or Steam Sterilization

[07630345727503]

Moist Heat or Steam Sterilization

[07630345727503]

Moist Heat or Steam Sterilization

[07630345727503]

Moist Heat or Steam Sterilization

[07630345727503]

Moist Heat or Steam Sterilization

[07630345727503]

Moist Heat or Steam Sterilization

[07630345727503]

Moist Heat or Steam Sterilization

[07630345727503]

Moist Heat or Steam Sterilization

[07630345727503]

Moist Heat or Steam Sterilization

[07630345727503]

Moist Heat or Steam Sterilization

[07630345727503]

Moist Heat or Steam Sterilization

[07630345727503]

Moist Heat or Steam Sterilization

[07630345727503]

Moist Heat or Steam Sterilization

[07630345727503]

Moist Heat or Steam Sterilization

[07630345727503]

Moist Heat or Steam Sterilization

[07630345727503]

Moist Heat or Steam Sterilization

[07630345727503]

Moist Heat or Steam Sterilization

[07630345727503]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-12-13
• Device Publish Date: 2021-12-03

On-Brand Devices [NextAR Spine Platform ]

• 07630971299719: NextAr Spine Target Large
• 07630971293199: NextAR Spine Camera Adapter
• 07630971292437: NextAR Spine MUST cann Tap Ø5mm undersized 0,5mm
• 07630971292413: NextAR Spine Needle for Awl
• 07630971292390: NextAR Spine MUST cann Tap Ø4,5mm undersized 0,3mm
• 07630971292383: NextAR Spine Screwdriver
• 07630971292376: NextAR Spine Camera Adapter for Screwdriver & Tap
• 07630971292369: NextAR Spine Pointer
• 07630971292352: NextAR Spine Awl
• 07630971292338: Sterile NextAR Spine Fiducial
• 07630345727121: NextAR Spine Probe Straight
• 07630345727114: NextAR Spine Drill Guide Handle
• 07630345727107: NextAR Spine Drill Guide Adapter
• 07630971292482: NextAR Spine MUST cann Tap Ø10mm undersized 0,5mm
• 07630971292475: NextAR Spine MUST cann Tap Ø9mm undersized 0,5mm
• 07630971292468: NextAR Spine MUST cann Tap Ø8mm undersized 0,5mm
• 07630971292451: NextAR Spine MUST cann Tap Ø7mm undersized 0,5mm
• 07630971292444: NextAR Spine MUST cann Tap Ø6mm undersized 0,5mm
• 07630345729279: NextAR Spine MIS screwdriver for MUST LT 25mm
• 07630345729262: NextAR Spine MIS screwdriver for MUST LT 15mm
• 07630345729255: MC Cortical Tap Cannulated 7mm
• 07630345729248: MC Cortical Tap Cannulated 6.5mm
• 07630345729231: MC Cortical Tap Cannulated 6mm
• 07630345729224: MC Cortical Tap Cannulated 5.5mm
• 07630345729217: MC Cortical Tap Cannulated 5mm
• 07630345729200: MC Cortical Tap Cannulated 4.5mm
• 07630345729194: MC Cortical Tap Cannulated 4mm
• 07630345727497: NextAR Spine Reduction Screwdriver Inner Shaft Can
• 07630345727411: Screwdriver Outer Shaft for MUST MC
• 07630345727404: Screwdriver Inner Shaft for MUST MC
• 07630345727244: NextAR Spine Screwdriver T15
• 07630345727237: NextAR Spine Probe curved
• 07630345727220: NextAR Spine Solid Tap Ø10mm
• 07630345727213: NextAR Spine Solid Tap Ø9mm
• 07630345727206: NextAR Spine Solid Tap Ø8mm
• 07630345727190: NextAR Spine Solid Tap Ø7mm
• 07630345727183: NextAR Spine Solid Solid Ø6mm
• 07630345727176: NextAR Spine Solid Tap Ø5mm
• 07630345727169: NextAR Spine Solid Tap Ø4,5mm
• 07630345710277: NextAR Spine Long Confidence Point
• 07630345710260: NextAR Spine Confidence Point
• 07630345710253: NextAR Spine Drill Guide Ø3,6
• 07630345710246: NextAR Spine Drill Guide Ø3,2
• 07630345710239: NextAR Spine Drill Guide Ø2,7
• 07630345710222: NextAR Spine Drill Guide Ø2,4
• 07630345710215: NextAR Spine Drill Guide Ø1,5
• 07630345710208: NextAR Spine Drill Guide Ø1,4
• 07630345729125: NextAR Spine tap aggressive undersize Ø6
• 07630345729118: NextAR Spine tap aggressive undersize Ø5
• 07630345729101: NextAR Spine tap aggressive undersize Ø4.5