Salvo® Robotic Navigation Instruments 10-8653

GUDID 10840642176612

Bone Screwdriver, T25

Spine Wave, Inc.

Surgical screwdriver, reusable

• Primary Device ID: 10840642176612
• NIH Device Record Key: 376ed669-1140-4a79-87dc-a42206d28695
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Salvo® Robotic Navigation Instruments
• Version Model Number: 10-8653
• Catalog Number: 10-8653
• Company DUNS: 067789763
• Company Name: Spine Wave, Inc.
• 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

Customer Support Contacts

• Phone: 203-944-9494
• Email: Info@spinewave.com
• Phone: 203-944-9494
• Email: Info@spinewave.com
• Phone: 203-944-9494
• Email: Info@spinewave.com
• Phone: 203-944-9494
• Email: Info@spinewave.com
• Phone: 203-944-9494
• Email: Info@spinewave.com
• Phone: 203-944-9494
• Email: Info@spinewave.com
• Phone: 203-944-9494
• Email: Info@spinewave.com
• Phone: 203-944-9494
• Email: Info@spinewave.com
• Phone: 203-944-9494
• Email: Info@spinewave.com
• Phone: 203-944-9494
• Email: Info@spinewave.com
• Phone: 203-944-9494
• Email: Info@spinewave.com
• Phone: 203-944-9494
• Email: Info@spinewave.com
• Phone: 203-944-9494
• Email: Info@spinewave.com
• Phone: 203-944-9494
• Email: Info@spinewave.com
• Phone: 203-944-9494
• Email: Info@spinewave.com
• Phone: 203-944-9494
• Email: Info@spinewave.com
• Phone: 203-944-9494
• Email: Info@spinewave.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840642176612 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243514

FDA Product Code

• OLO: Orthopedic Stereotaxic Instrument

Sterilization

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

[10840642176612]

Moist Heat or Steam Sterilization

[10840642176612]

Moist Heat or Steam Sterilization

[10840642176612]

Moist Heat or Steam Sterilization

[10840642176612]

Moist Heat or Steam Sterilization

[10840642176612]

Moist Heat or Steam Sterilization

[10840642176612]

Moist Heat or Steam Sterilization

[10840642176612]

Moist Heat or Steam Sterilization

[10840642176612]

Moist Heat or Steam Sterilization

[10840642176612]

Moist Heat or Steam Sterilization

[10840642176612]

Moist Heat or Steam Sterilization

[10840642176612]

Moist Heat or Steam Sterilization

[10840642176612]

Moist Heat or Steam Sterilization

[10840642176612]

Moist Heat or Steam Sterilization

[10840642176612]

Moist Heat or Steam Sterilization

[10840642176612]

Moist Heat or Steam Sterilization

[10840642176612]

Moist Heat or Steam Sterilization

[10840642176612]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-09
• Device Publish Date: 2025-05-01

Devices Manufactured by Spine Wave, Inc.

• 10840642175585 - Salvo® Spine System: 2025-05-09 XT Screwdriver, 5.5/6.0 mm, T25, NAV-M
• 10840642176612 - Salvo® Robotic Navigation Instruments: 2025-05-09Bone Screwdriver, T25
• 10840642176612 - Salvo® Robotic Navigation Instruments: 2025-05-09 Bone Screwdriver, T25
• 10840642159400 - Salvo® Spine System: 2025-02-28 6.5 mm Extended Tap, 3 mm Pitch, Cannulated
• 10840642159424 - Salvo® Spine System: 2025-02-28 7.5 mm Extended Tap, 3 mm Pitch, Cannulated
• 10840642154498 - Salvo® Spine System: 2025-02-04 Screwdriver, Bone Screw, T25
• 10840642154504 - Salvo® Spine System: 2025-02-04 Screwdriver, 4.75 mm, T25
• 10840642159707 - Salvo® Spine System: 2025-02-04 Double Ended Locking Screw Inserter, 5.5/6.0 mm
• 10840642159714 - Salvo® Spine System: 2025-02-04 Locking Screw Inserter, 5.5/6.0 mm