WaveForm™ C AC1-264121

GUDID 10889981220310

Interbody, 16x14x12mm, 10 Degree, 3D

SEASPINE ORTHOPEDICS CORPORATION

Metallic spinal interbody fusion cage

• Primary Device ID: 10889981220310
• NIH Device Record Key: f5e73480-a3fe-4437-bbef-466386ec7535
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: WaveForm™ C
• Version Model Number: AC1-264121
• Catalog Number: AC1-264121
• 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	10889981220310 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K201073

FDA Product Code

• ODP: Intervertebral fusion device with bone graft, 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]

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• 10889981220143: Interbody, 16x14x6mm, 10 Degree, 3D
• 10889981220136: Interbody, 16x14x5mm, 7 Degree, 3D
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• 10889981220020: Interbody, 14x13x7mm, 7 Degree, 3D
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• 10889981219741: Interbody, 20x15x10mm, 7 Degree, 3D
• 10889981219727: Interbody, 20x15x10mm, 10 Degree, 3D
• 10889981219710: Interbody, 20x15x9mm, 7 Degree, 3D
• 10889981219697: Interbody, 20x15x9mm, 10 Degree, 3D
• 10889981219680: Interbody, 20x15x8mm, 7 Degree, 3D
• 10889981219666: Interbody, 20x15x8mm, 10 Degree, 3D
• 10889981219659: Interbody, 20x15x7mm, 7 Degree, 3D
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• 10889981219635: Interbody, 20x15x6mm, 7 Degree, 3D
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• 10889981219611: Interbody, 20x15x5mm, 7 Degree, 3D