Annex® 2 Adjacent Level System 10-9205

GUDID 10840642173970

Swivel Hook Inserter Rod Indicator

Spine Wave, Inc.

Orthopaedic prosthesis implantation positioning instrument, reusable

• Primary Device ID: 10840642173970
• NIH Device Record Key: fb9258dc-68fb-4648-99d8-592408f11e05
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Annex® 2 Adjacent Level System
• Version Model Number: 10-9205
• Catalog Number: 10-9205
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840642173970 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K251131

FDA Product Code

• NKB: Thoracolumbosacral Pedicle Screw System

Sterilization

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

[10840642173970]

Moist Heat or Steam Sterilization

[10840642173970]

Moist Heat or Steam Sterilization

[10840642173970]

Moist Heat or Steam Sterilization

[10840642173970]

Moist Heat or Steam Sterilization

[10840642173970]

Moist Heat or Steam Sterilization

[10840642173970]

Moist Heat or Steam Sterilization

[10840642173970]

Moist Heat or Steam Sterilization

[10840642173970]

Moist Heat or Steam Sterilization

[10840642173970]

Moist Heat or Steam Sterilization

[10840642173970]

Moist Heat or Steam Sterilization

[10840642173970]

Moist Heat or Steam Sterilization

[10840642173970]

Moist Heat or Steam Sterilization

[10840642173970]

Moist Heat or Steam Sterilization

[10840642173970]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-01-19
• Device Publish Date: 2026-01-09

On-Brand Devices [Annex® 2 Adjacent Level System]

• 10840642177121: Axial C Connector Locking Screw
• 10840642176506: Axial C Trial, 6.0 mm
• 10840642176490: Axial C Trial, 5.5 mm
• 10840642176483: Axial C Trial, 4.75 mm
• 10840642175608: Annex® 2 Template
• 10840642173987: Annex® 2 Device Indicator
• 10840642173970: Swivel Hook Inserter Rod Indicator
• 10840642173963: Annex® 2 Device Inserter
• 10840642173581: Swivel Hook Inserter
• 10840642173093: Annex® 2 Device Locking Screw
• 10840642173086: Swivel Connector Locking Screw
• 10840642173024: Axial C Connector Inserter
• 10840642173000: Annex® 2 Device Trial, Full Jog, Short
• 10840642172980: Annex® 2 Device Trial, Half Jog, Short
• 10840642172973: Annex® 2 Device Trial, No Jog
• 10840642172966: Swivel Hook Trial, 6.0 mm
• 10840642172959: Swivel Hook Trial, 5.5 mm
• 10840642172942: Swivel Hook Trial, 4.75 mm
• 10840642171440: Counter Torque
• 10840642179330: Bottom Tray, Implant Set
• 10840642178319: Top Tray, Implant Set
• 10840642176971: Pin Mat, Instrument Set
• 10840642176964: Caddy, Axial C Connector and Locking Screws
• 10840642175394: Base, Instrument Set
• 10840642175387: Base, Implant Set
• 10840642175370: Bottom Tray, Instrument Set
• 10840642175363: Top Tray, Instrument Set
• 10840642175356: Caddy, Parallel Connectors
• 10840642175349: Caddy, Annex® 2 Device, Short and Locking Screws
• 10840642175332: Caddy, Annex® 2 Device, Long and Locking Screws
• 10840642175325: Caddy, Swivel Connector and Locking Screws