WaveForm™ TO WO1-924165

GUDID 10889981234928

Interbody, 9mm x 24mm x 16mm, 15 Deg, 3D

SEASPINE ORTHOPEDICS CORPORATION

Metallic spinal interbody fusion cage

• Primary Device ID: 10889981234928
• NIH Device Record Key: a05f470f-5b75-40e6-90fe-b049f24025cb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WaveForm™ TO
• Version Model Number: WO1-924165
• Catalog Number: WO1-924165
• Company DUNS: 079840876
• Company Name: SEASPINE ORTHOPEDICS CORPORATION
• 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: true
• 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

Customer Support Contacts

• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com
• Phone: +1(760)727-8399
• Email: custsvcspine@seaspine.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981234928 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201755

FDA Product Code

• MAX: Intervertebral fusion device with bone graft, lumbar

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-08-09
• Device Publish Date: 2021-07-30

On-Brand Devices [WaveForm™ TO]

• 10889981234928: Interbody, 9mm x 24mm x 16mm, 15 Deg, 3D
• 10889981234843: Interbody, 9mm x 24mm x 14mm, 15 Deg, 3D
• 10889981234768: Interbody, 9mm x 24mm x 12mm, 15 Deg, 3D
• 10889981234683: Interbody, 9mm x 24mm x 10mm, 15 Deg, 3D