WaveForm TO WO1-928165

GUDID 10889981235338

Interbody, 9mm x 28mm x 16mm, 15 Deg, 3D

SEASPINE ORTHOPEDICS CORPORATION

Metallic spinal interbody fusion cage

• Primary Device ID: 10889981235338
• NIH Device Record Key: aae97a1e-abdb-436a-8761-aac4861e8df0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WaveForm TO
• Version Model Number: WO1-928165
• Catalog Number: WO1-928165
• 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: 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: +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	10889981235338 [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: 2021-05-12
• Device Publish Date: 2021-05-04

On-Brand Devices [WaveForm TO]

• 10889981240066: Interbody, 9mm x 28mm x 8mm, 10 Deg, 3D
• 10889981240059: Interbody, 11mm x 32mm x 9mm, 10 Deg, 3D
• 10889981240042: Interbody, 11mm x 28mm x 8mm, 10 Deg, 3D
• 10889981237974: Interbody, 9mm x 28mm x 10mm, 15 Deg, 3D
• 10889981237967: Interbody, 9mm x 28mm x 9mm, 10 Deg, 3D
• 10889981237950: Interbody, 9mm x 24mm x 8mm, 10 Deg, 3D
• 10889981237943: Interbody, 11mm x 28mm x 10mm, 15 Deg, 3D
• 10889981237936: Interbody, 11mm x 28mm x 9mm, 10 Deg, 3D
• 10889981235338: Interbody, 9mm x 28mm x 16mm, 15 Deg, 3D
• 10889981235321: Interbody, 9mm x 28mm x 16mm, 5 Deg, 3D
• 10889981235307: Interbody, 9mm x 28mm x 16mm, 10 Deg, 3D
• 10889981235291: Interbody, 9mm x 28mm x 15mm, 15 Deg, 3D
• 10889981235284: Interbody, 9mm x 28mm x 15mm, 5 Deg, 3D
• 10889981235260: Interbody, 9mm x 28mm x 15mm, 10 Deg, 3D
• 10889981235253: Interbody, 9mm x 28mm x 14mm, 15 Deg, 3D
• 10889981235246: Interbody, 9mm x 28mm x 14mm, 5 Deg, 3D
• 10889981235222: Interbody, 9mm x 28mm x 14mm, 10 Deg, 3D
• 10889981235215: Interbody, 9mm x 28mm x 13mm, 15 Deg, 3D
• 10889981235208: Interbody, 9mm x 28mm x 13mm, 5 Deg, 3D
• 10889981235185: Interbody, 9mm x 28mm x 13mm, 10 Deg, 3D
• 10889981235178: Interbody, 9mm x 28mm x 12mm, 15 Deg, 3D
• 10889981235161: Interbody, 9mm x 28mm x 12mm, 5 Deg, 3D
• 10889981235147: Interbody, 9mm x 28mm x 12mm, 10 Deg, 3D
• 10889981235130: Interbody, 9mm x 28mm x 11mm, 15 Deg, 3D
• 10889981235123: Interbody, 9mm x 28mm x 11mm, 5 Deg, 3D
• 10889981235109: Interbody, 9mm x 28mm x 11mm, 10 Deg, 3D
• 10889981235093: Interbody, 9mm x 28mm x 10mm, 5 Deg, 3D
• 10889981235079: Interbody, 9mm x 28mm x 10mm, 10 Deg, 3D
• 10889981235062: Interbody, 9mm x 28mm x 9mm, 5 Deg, 3D
• 10889981235048: Interbody, 9mm x 28mm x 8mm, 5 Deg, 3D
• 10889981235024: Interbody, 9mm x 28mm x 7mm, 5 Deg, 3D
• 10889981234904: Interbody, 9mm x 24mm x 16mm, 10 Deg, 3D
• 10889981234867: Interbody, 9mm x 24mm x 15mm, 10 Deg, 3D
• 10889981234829: Interbody, 9mm x 24mm x 14mm, 10 Deg, 3D
• 10889981234782: Interbody, 9mm x 24mm x 13mm, 10 Deg, 3D
• 10889981234744: Interbody, 9mm x 24mm x 12mm, 10 Deg, 3D
• 10889981234706: Interbody, 9mm x 24mm x 11mm, 10 Deg, 3D
• 10889981234669: Interbody, 9mm x 24mm x 10mm, 10 Deg, 3D
• 10889981234638: Interbody, 9mm x 24mm x 9mm, 10 Deg, 3D
• 10889981233501: Interbody, 11mm x 32mm x 16mm, 10 Deg, 3D
• 10889981233464: Interbody, 11mm x 32mm x 15mm, 10 Deg, 3D
• 10889981233426: Interbody, 11mm x 32mm x 14mm, 10 Deg, 3D
• 10889981233389: Interbody, 11mm x 32mm x 13mm, 10 Deg, 3D
• 10889981233341: Interbody, 11mm x 32mm x 12mm, 10 Deg, 3D
• 10889981233303: Interbody, 11mm x 32mm x 11mm, 10 Deg, 3D
• 10889981233273: Interbody, 11mm x 32mm x 10mm, 10 Deg, 3D
• 10889981233129: Interbody, 11mm x 28mm x 16mm, 15 Deg, 3D
• 10889981233112: Interbody, 11mm x 28mm x 16mm, 5 Deg, 3D
• 10889981233099: Interbody, 11mm x 28mm x 16mm, 10 Deg, 3D
• 10889981233082: Interbody, 11mm x 28mm x 15mm, 15 Deg, 3D