WaveForm TA WT1-932138

GUDID 10889981243715

Interbody, 9mm x 32mm x 13mm, 8 Deg, 3D

SEASPINE ORTHOPEDICS CORPORATION

Metallic spinal interbody fusion cage

• Primary Device ID: 10889981243715
• NIH Device Record Key: 654e3154-c120-4ed4-a44e-b2225c158c09
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WaveForm TA
• Version Model Number: WT1-932138
• Catalog Number: WT1-932138
• 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
• 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
• 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	10889981243715 [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: 2021-02-15
• Device Publish Date: 2021-02-06

On-Brand Devices [WaveForm TA]

• 10889981243791: Interbody, 9mm x 32mm x 15mm, 8 Deg, 3D
• 10889981243784: Interbody, 9mm x 32mm x 15mm, 15 Deg, 3D
• 10889981243753: Interbody, 9mm x 32mm x 14mm, 8 Deg, 3D
• 10889981243746: Interbody, 9mm x 32mm x 14mm, 15 Deg, 3D
• 10889981243715: Interbody, 9mm x 32mm x 13mm, 8 Deg, 3D
• 10889981243708: Interbody, 9mm x 32mm x 13mm, 15 Deg, 3D
• 10889981243678: Interbody, 9mm x 32mm x 12mm, 8 Deg, 3D
• 10889981243661: Interbody, 9mm x 32mm x 12mm, 15 Deg, 3D
• 10889981243630: Interbody, 9mm x 32mm x 11mm, 8 Deg, 3D
• 10889981243623: Interbody, 9mm x 32mm x 11mm, 15 Deg, 3D
• 10889981243593: Interbody, 9mm x 32mm x 10mm, 8 Deg, 3D
• 10889981243586: Interbody, 9mm x 32mm x 10mm, 15 Deg, 3D
• 10889981243555: Interbody, 9mm x 32mm x 9mm, 8 Deg, 3D
• 10889981243548: Interbody, 9mm x 32mm x 9mm, 15 Deg, 3D
• 10889981243524: Interbody, 9mm x 32mm x 8mm, 8 Deg, 3D
• 10889981243371: Interbody, 9mm x 28mm x 15mm, 8 Deg, 3D
• 10889981243333: Interbody, 9mm x 28mm x 14mm, 8 Deg, 3D
• 10889981243296: Interbody, 9mm x 28mm x 13mm, 8 Deg, 3D
• 10889981243258: Interbody, 9mm x 28mm x 12mm, 8 Deg, 3D
• 10889981243210: Interbody, 9mm x 28mm x 11mm, 8 Deg, 3D
• 10889981243173: Interbody, 9mm x 28mm x 10mm, 8 Deg, 3D
• 10889981243135: Interbody, 9mm x 28mm x 9mm, 8 Deg, 3D
• 10889981243104: Interbody, 9mm x 28mm x 8mm, 8 Deg, 3D
• 10889981242534: Interbody, 11mm x 36mm x 15mm, 8 Deg, 3D
• 10889981242497: Interbody, 11mm x 36mm x 14mm, 8 Deg, 3D
• 10889981242459: Interbody, 11mm x 36mm x 13mm, 8 Deg, 3D
• 10889981242411: Interbody, 11mm x 36mm x 12mm, 8 Deg, 3D
• 10889981242374: Interbody, 11mm x 36mm x 11mm, 8 Deg, 3D
• 10889981242336: Interbody, 11mm x 36mm x 10mm, 8 Deg, 3D
• 10889981242299: Interbody, 11mm x 36mm x 9mm, 8 Deg, 3D
• 10889981242268: Interbody, 11mm x 36mm x 8mm, 8 Deg, 3D