NextAR RSA Platform

GUDID 07630345731159

NextAR K-wire guide - right

Medacta International SA

Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system Optical surgical navigation device tracking system

• Primary Device ID: 07630345731159
• NIH Device Record Key: 4d2f85f6-8f78-40d6-a673-6caca1704120
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NextAR RSA Platform
• Version Model Number: 04.01.10.0587
• 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	07630345731159 [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

[07630345731159]

Moist Heat or Steam Sterilization

[07630345731159]

Moist Heat or Steam Sterilization

[07630345731159]

Moist Heat or Steam Sterilization

[07630345731159]

Moist Heat or Steam Sterilization

[07630345731159]

Moist Heat or Steam Sterilization

[07630345731159]

Moist Heat or Steam Sterilization

[07630345731159]

Moist Heat or Steam Sterilization

[07630345731159]

Moist Heat or Steam Sterilization

[07630345731159]

Moist Heat or Steam Sterilization

[07630345731159]

Moist Heat or Steam Sterilization

[07630345731159]

Moist Heat or Steam Sterilization

[07630345731159]

Moist Heat or Steam Sterilization

[07630345731159]

Moist Heat or Steam Sterilization

[07630345731159]

Moist Heat or Steam Sterilization

[07630345731159]

Moist Heat or Steam Sterilization

[07630345731159]

Moist Heat or Steam Sterilization

[07630345731159]

Moist Heat or Steam Sterilization

[07630345731159]

Moist Heat or Steam Sterilization

[07630345731159]

Moist Heat or Steam Sterilization

[07630345731159]

Moist Heat or Steam Sterilization

[07630345731159]

Moist Heat or Steam Sterilization

[07630345731159]

Moist Heat or Steam Sterilization

[07630345731159]

Moist Heat or Steam Sterilization

[07630345731159]

Moist Heat or Steam Sterilization

[07630345731159]

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