Accelus Robotic Navigation System 1061

GUDID 00850026574500

MIS Driver

Fusion Robotics, LLC

Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable Surgical screwdriver, reusable

• Primary Device ID: 00850026574500
• NIH Device Record Key: 53e7cdc2-5eed-4140-bb53-f60ea5792455
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Accelus Robotic Navigation System
• Version Model Number: 1061
• Catalog Number: 1061
• Company DUNS: 117229400
• Company Name: Fusion Robotics, LLC
• 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	00850026574500 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202184

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[00850026574500]

Moist Heat or Steam Sterilization

[00850026574500]

Moist Heat or Steam Sterilization

[00850026574500]

Moist Heat or Steam Sterilization

[00850026574500]

Moist Heat or Steam Sterilization

[00850026574500]

Moist Heat or Steam Sterilization

[00850026574500]

Moist Heat or Steam Sterilization

[00850026574500]

Moist Heat or Steam Sterilization

[00850026574500]

Moist Heat or Steam Sterilization

[00850026574500]

Moist Heat or Steam Sterilization

[00850026574500]

Moist Heat or Steam Sterilization

[00850026574500]

Moist Heat or Steam Sterilization

[00850026574500]

Moist Heat or Steam Sterilization

[00850026574500]

Moist Heat or Steam Sterilization

[00850026574500]

Moist Heat or Steam Sterilization

[00850026574500]

Moist Heat or Steam Sterilization

[00850026574500]

Moist Heat or Steam Sterilization

[00850026574500]

Moist Heat or Steam Sterilization

[00850026574500]

Moist Heat or Steam Sterilization

[00850026574500]

Moist Heat or Steam Sterilization

[00850026574500]

Moist Heat or Steam Sterilization

[00850026574500]

Moist Heat or Steam Sterilization

[00850026574500]

Moist Heat or Steam Sterilization

[00850026574500]

Moist Heat or Steam Sterilization

[00850026574500]

Moist Heat or Steam Sterilization

[00850026574500]

Moist Heat or Steam Sterilization

[00850026574500]

Moist Heat or Steam Sterilization

[00850026574500]

Moist Heat or Steam Sterilization

[00850026574500]

Moist Heat or Steam Sterilization

[00850026574500]

Moist Heat or Steam Sterilization

[00850026574500]

Moist Heat or Steam Sterilization

[00850026574500]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-07
• Device Publish Date: 2021-09-29

Devices Manufactured by Fusion Robotics, LLC

• 00850026574661 - REMI Robotic Navigation System: 2023-03-28 REMI 4.5 mm Cann. Dual Lead Tap
• 00850026574678 - REMI Robotic Navigation System: 2023-03-28 REMI 5.0 mm Cann. Dual Lead Tap
• 00850026574685 - REMI Robotic Navigation System: 2023-03-28 REMI 5.5 mm Cann. Dual Lead Tap
• 00850026574692 - REMI Robotic Navigation System: 2023-03-28 REMI 6.5 mm Cann. Dual Lead Tap
• 00850026574708 - REMI Robotic Navigation System: 2023-03-28 REMI 7.5 mm Cann. Dual Lead Tap
• 00850026574722 - REMI Robotic Navigation System: 2023-03-28 REMI 8.5 mm Cann. Dual Lead Tap
• 00850026574555 - REMI Robotic Navigation System: 2022-07-01 150mm x 6mm PSIS Pin
• 00850026574579 - REMI Robotic Navigation System: 2022-07-01 100mm x 6mm PSIS Pin