NextAR (TM) Shoulder Platform

GUDID 07630542779008

NextAR GRS full wedge one-step reamer - 15°

Medacta International SA

Optical surgical navigation device tracking system

• Primary Device ID: 07630542779008
• NIH Device Record Key: 95946ca2-fb8a-493f-978d-465cb0a58969
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NextAR (TM) Shoulder Platform
• Version Model Number: 04.01.10.1148
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	07630542779008 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K251737

FDA Product Code

• SBF: Orthopedic Augmented Reality

Sterilization

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

[07630542779008]

Moist Heat or Steam Sterilization

[07630542779008]

Moist Heat or Steam Sterilization

[07630542779008]

Moist Heat or Steam Sterilization

[07630542779008]

Moist Heat or Steam Sterilization

[07630542779008]

Moist Heat or Steam Sterilization

[07630542779008]

Moist Heat or Steam Sterilization

[07630542779008]

Moist Heat or Steam Sterilization

[07630542779008]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-09-25
• Device Publish Date: 2025-09-17

On-Brand Devices [NextAR (TM) Shoulder Platform]

• 07630542779015: NextAR GRS full wedge one-step reamer - 20°
• 07630542779008: NextAR GRS full wedge one-step reamer - 15°
• 07630542778995: NextAR GRS full wedge one-step reamer - 10°
• 07630542765445: NextAR flat angled reamer - 30°
• 07630542765438: NextAR flat angled reamer - 20°
• 07630542765421: NextAR flat angled reamer - 10°
• 07630542765414: Straight ratchet handle - ZH
• 07630542765407: Straight ratchet handle - AO
• 07630542765391: NextAR GRS central screw tap - ZH
• 07630542765384: NextAR GRS central screw tap - AO
• 07630542765360: NextAR GRS full wedge reamer - 20°
• 07630542765353: NextAR GRS full wedge reamer - 15°
• 07630542765346: NextAR GRS full wedge reamer - 10°
• 07630542765339: NextAR glenoid camera holder