NextAR™ Spine

GUDID 07630542784859

NextAR Smart Glasses BOX- Epson Moverio

Medacta International SA

Optical surgical navigation device tracking system

• Primary Device ID: 07630542784859
• NIH Device Record Key: bf805dd5-e1f9-494e-bf8c-ee40cacf407f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NextAR™ Spine
• Version Model Number: 09.23.10.EM-ARG003
• 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: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630542784859 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250477

FDA Product Code

• SBF: Orthopedic Augmented Reality

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-28
• Device Publish Date: 2025-08-20

On-Brand Devices [NextAR™ Spine]

• 07630542784873: NextAR Smart Glasses Controller - Epson Moverio
• 07630542784866: NextAR Smart Glasses - Epson Moverio
• 07630542784859: NextAR Smart Glasses BOX- Epson Moverio
• 07630542741890: NextAR Spine Longer Drill Guide Camera Adapter
• 07630542741876: NextAR Spine Iliac Crest Pin Remover
• 07630542741869: NextAR Spine Needle for Longer Awl
• 07630542741692: NextAR Spine S2AI Screwdriver T20 Outer Shaft
• 07630542741685: NextAR Spine S2AI Screwdriver T20 Inner Shaft
• 07630542741678: NextAR Spine S2AI Screwdriver T25 Outer Shaft
• 07630542741661: NextAR Spine S2AI Screwdriver T25 Inner Shaft
• 07630542741425: NextAR Spine Sterile Iliac Pin Long
• 07630542741418: NextAR Spine Sterile Iliac Pin Medium
• 07630542741401: NextAR Spine Sterile Iliac Pin Short
• 07630542741395: NextAR Spine Iliac Pin Medium
• 07630542741388: NextAR Spine Iliac Pin Long
• 07630542741371: NextAR Spine Iliac Pin Short
• 07630542739613: NextAR Spine Longer Pointer
• 07630542739606: NextAR Longer Awl
• 07630542739590: NextAR Spine Longer Probe Curved
• 07630542739583: NextAR Spine Longer Probe Straight
• 07630542735394: NextAR Spine Clamp for Adjustable Mounting
• 07630542735387: NextAR Spine Adjustable Double Mounting
• 07630542735370: NextAR Spine Iliac Mounting Left
• 07630542735363: NextAR Spine Iliac Mounting Right