WaveForm ™ C AC1-285091

GUDID 10889981220426

Interbody, 18x15x9mm, 10 Degree, 3D

SEASPINE ORTHOPEDICS CORPORATION

Metallic spinal interbody fusion cage

• Primary Device ID: 10889981220426
• NIH Device Record Key: 93163962-f69a-415b-8855-a2f066d2a546
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WaveForm ™ C
• Version Model Number: AC1-285091
• Catalog Number: AC1-285091
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981220426 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201073

FDA Product Code

• OVE: Intervertebral fusion device with integrated fixation, cervical

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: 2020-10-27
• Device Publish Date: 2020-10-19

On-Brand Devices [WaveForm ™ C]

• 10889981220532: Interbody, 18x15x12mm, 7 Degree, 3D
• 10889981220518: Interbody, 18x15x12mm, 10 Degree, 3D
• 10889981220501: Interbody, 18x15x11mm, 7 Degree, 3D
• 10889981220488: Interbody, 18x15x11mm, 10 Degree, 3D
• 10889981220471: Interbody, 18x15x10mm, 7 Degree, 3D
• 10889981220457: Interbody, 18x15x10mm, 10 Degree, 3D
• 10889981220440: Interbody, 18x15x9mm, 7 Degree, 3D
• 10889981220426: Interbody, 18x15x9mm, 10 Degree, 3D
• 10889981220419: Interbody, 18x15x8mm, 7 Degree, 3D
• 10889981220396: Interbody, 18x15x8mm, 10 Degree, 3D