3D Printed Interbody Systems AC4-185077

GUDID 10889981280970

No Profile Spacer, 18x15x7mm, 7 Degree, 3D

SEASPINE ORTHOPEDICS CORPORATION

Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage Metallic spinal interbody fusion cage

• Primary Device ID: 10889981280970
• NIH Device Record Key: 4e4bc9d8-bd09-4796-9d62-b992270dd11f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3D Printed Interbody Systems
• Version Model Number: AC4-185077
• Catalog Number: AC4-185077
• 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	10889981280970 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213359

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