3D Printed Interbody Systems AC4-264091

GUDID 10889981281816

Interbody, 16x14x9mm, 10 Degree, 3D

SEASPINE ORTHOPEDICS CORPORATION

Metallic spinal interbody fusion cage

• Primary Device ID: 10889981281816
• NIH Device Record Key: 097076a1-b589-4e99-9ea4-e7326129624c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3D Printed Interbody Systems
• Version Model Number: AC4-264091
• Catalog Number: AC4-264091
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981281816 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212904

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: 2022-08-22
• Device Publish Date: 2022-08-12

On-Brand Devices [3D Printed Interbody Systems]

• 10889981282127: Interbody, 18x15x12mm, 7 Degree, 3D
• 10889981282110: Interbody, 18x15x12mm, 15 Degree, 3D
• 10889981282103: Interbody, 18x15x12mm, 10 Degree, 3D
• 10889981282097: Interbody, 18x15x11mm, 7 Degree, 3D
• 10889981282080: Interbody, 18x15x11mm, 15 Degree, 3D
• 10889981282073: Interbody, 18x15x11mm, 10 Degree, 3D
• 10889981282066: Interbody, 18x15x10mm, 7 Degree, 3D
• 10889981282059: Interbody, 18x15x10mm, 15 Degree, 3D
• 10889981282042: Interbody, 18x15x10mm, 10 Degree, 3D
• 10889981282035: Interbody, 18x15x9mm, 7 Degree, 3D
• 10889981282028: Interbody, 18x15x9mm, 15 Degree, 3D
• 10889981282011: Interbody, 18x15x9mm, 10 Degree, 3D
• 10889981282004: Interbody, 18x15x8mm, 7 Degree, 3D
• 10889981281991: Interbody, 18x15x8mm, 15 Degree, 3D
• 10889981281984: Interbody, 18x15x8mm, 10 Degree, 3D
• 10889981281977: Interbody, 18x15x7mm, 7 Degree, 3D
• 10889981281960: Interbody, 18x15x7mm, 10 Degree, 3D
• 10889981281953: Interbody, 18x15x6mm, 7 Degree, 3D
• 10889981281946: Interbody, 18x15x6mm, 10 Degree, 3D
• 10889981281939: Interbody, 18x15x5mm, 7 Degree, 3D
• 10889981281922: Interbody, 16x14x12mm, 7 Degree, 3D
• 10889981281915: Interbody, 16x14x12mm, 15 Degree, 3D
• 10889981281908: Interbody, 16x14x12mm, 10 Degree, 3D
• 10889981281892: Interbody, 16x14x11mm, 7 Degree, 3D
• 10889981281885: Interbody, 16x14x11mm, 15 Degree, 3D
• 10889981281878: Interbody, 16x14x11mm, 10 Degree, 3D
• 10889981281861: Interbody, 16x14x10mm, 7 Degree, 3D
• 10889981281854: Interbody, 16x14x10mm, 15 Degree, 3D
• 10889981281847: Interbody, 16x14x10mm, 10 Degree, 3D
• 10889981281830: Interbody, 16x14x9mm, 7 Degree, 3D
• 10889981281823: Interbody, 16x14x9mm, 15 Degree, 3D
• 10889981281816: Interbody, 16x14x9mm, 10 Degree, 3D
• 10889981281809: Interbody, 16x14x8mm, 7 Degree, 3D
• 10889981281793: Interbody, 16x14x8mm, 15 Degree, 3D
• 10889981281786: Interbody, 16x14x8mm, 10 Degree, 3D
• 10889981281779: Interbody, 16x14x7mm, 7 Degree, 3D
• 10889981281762: Interbody, 16x14x7mm, 15 Degree, 3D
• 10889981281755: Interbody, 16x14x7mm, 10 Degree, 3D
• 10889981281748: Interbody, 16x14x6mm, 7 Degree, 3D
• 10889981281731: Interbody, 16x14x6mm, 10 Degree, 3D
• 10889981281724: Interbody, 16x14x5mm, 7 Degree, 3D
• 10889981281717: Interbody, 16x12x12mm, 7 Degree, 3D
• 10889981281700: Interbody, 16x12x5mm, 15 Degree, 3D
• 10889981281694: Interbody, 16x12x12mm, 10 Degree, 3D
• 10889981281687: Interbody, 16x12x11mm, 7 Degree, 3D
• 10889981281670: Interbody, 16x12x5mm, 15 Degree, 3D
• 10889981281663: Interbody, 16x12x11mm, 10 Degree, 3D
• 10889981281656: Interbody, 16x12x10mm, 7 Degree, 3D
• 10889981281649: Interbody, 16x12x5mm, 15 Degree, 3D
• 10889981281632: Interbody, 16x12x10mm, 10 Degree, 3D