Salvo® XRS Robotic Navigation Instrument System 10-8819

GUDID 10840642176681

Awl-Tip Tap, 6.5 mm, 3 mm Pitch

Spine Wave, Inc.

Bone tap, reusable

• Primary Device ID: 10840642176681
• NIH Device Record Key: ea7eb7dd-0dc0-4bdd-9513-fd86ce7bef53
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Salvo® XRS Robotic Navigation Instrument System
• Version Model Number: 10-8819
• Catalog Number: 10-8819
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840642176681 [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

[10840642176681]

Moist Heat or Steam Sterilization

[10840642176681]

Moist Heat or Steam Sterilization

[10840642176681]

Moist Heat or Steam Sterilization

[10840642176681]

Moist Heat or Steam Sterilization

[10840642176681]

Moist Heat or Steam Sterilization

[10840642176681]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-11-21
• Device Publish Date: 2025-11-13

On-Brand Devices [Salvo® XRS Robotic Navigation Instrument System]

• 10840642176940: Registration Screwdriver
• 10840642176858: Awl-Tip Tap, 7.5 mm, 2 mm Pitch
• 10840642176834: Awl-Tip Tap, 6.5 mm, 2 mm Pitch
• 10840642176810: Awl-Tip Tap, 5.5 mm, 2 mm Pitch
• 10840642176797: Awl-Tip Tap, 4.5 mm, 2 mm Pitch
• 10840642176780: Awl-Tip Tap, 4.0 mm, 2 mm Pitch
• 10840642176704: Awl-Tip Tap, 7.5 mm, 3 mm Pitch
• 10840642176681: Awl-Tip Tap, 6.5 mm, 3 mm Pitch
• 10840642176667: Awl-Tip Tap, 5.5 mm, 3 mm Pitch
• 10840642176643: Awl-Tip Tap, 4.5 mm, 3 mm Pitch
• 10840642176636: Awl-Tip Tap, 4.0 mm, 3 mm Pitch
• 10840642176629: Screwdriver, 5.5/6.0, T25