NextAR RSA Platform

GUDID 07630345731166

NextAR K-wire guide - left

Medacta International SA

Optical surgical navigation device tracking system

• Primary Device ID: 07630345731166
• NIH Device Record Key: ba09854f-d965-49ae-903f-fa0a2cac7f4e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NextAR RSA Platform
• Version Model Number: 04.01.10.0588
• 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	07630345731166 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210153

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[07630345731166]

Moist Heat or Steam Sterilization

[07630345731166]

Moist Heat or Steam Sterilization

[07630345731166]

Moist Heat or Steam Sterilization

[07630345731166]

Moist Heat or Steam Sterilization

[07630345731166]

Moist Heat or Steam Sterilization

[07630345731166]

Moist Heat or Steam Sterilization

[07630345731166]

Moist Heat or Steam Sterilization

[07630345731166]

Moist Heat or Steam Sterilization

[07630345731166]

Moist Heat or Steam Sterilization

[07630345731166]

Moist Heat or Steam Sterilization

[07630345731166]

Moist Heat or Steam Sterilization

[07630345731166]

Moist Heat or Steam Sterilization

[07630345731166]

Moist Heat or Steam Sterilization

[07630345731166]

Moist Heat or Steam Sterilization

[07630345731166]

Moist Heat or Steam Sterilization

[07630345731166]

Moist Heat or Steam Sterilization

[07630345731166]

Moist Heat or Steam Sterilization

[07630345731166]

Moist Heat or Steam Sterilization

[07630345731166]

Moist Heat or Steam Sterilization

[07630345731166]

Moist Heat or Steam Sterilization

[07630345731166]

Moist Heat or Steam Sterilization

[07630345731166]

Moist Heat or Steam Sterilization

[07630345731166]

Moist Heat or Steam Sterilization

[07630345731166]

Moist Heat or Steam Sterilization

[07630345731166]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-06-29
• Device Publish Date: 2021-06-21

On-Brand Devices [NextAR RSA Platform ]

• 07630345731227: NextAR tracker holder - left
• 07630345731210: NextAR glenosphere impactor
• 07630345731203: NextAR drill guide for peripheral screws -left
• 07630345731197: NextAR drill guide for peripheral screws - right
• 07630345731180: NextAR impaction handle
• 07630345731173: Modular handle for driving shaft
• 07630345731166: NextAR K-wire guide - left
• 07630345731159: NextAR K-wire guide - right
• 07630345731142: NextAR pointer - left
• 07630345731135: NextAR pointer - right
• 07630345731128: NextAR tracker holder - right
• 07630345731111: Drill guide for slim EasyClip
• 07630345731104: Slim EasyClip
• 07630345727558: NextAR driving shaft - ZH
• 07630345727541: NextAR driving shaft - AO
• 07630542702211: NextAR inserter for threaded baseplate - AO
• 07630542702204: NextAR inserter - M5 shaft