Mariner Deformity MD1-114545

GUDID 10889981235581

Uni-Planar Screw, 4.5mm X 45mm

SEASPINE ORTHOPEDICS CORPORATION

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 10889981235581
• NIH Device Record Key: df96da74-5eba-4395-87d3-658fa65adc92
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mariner Deformity
• Version Model Number: MD1-114545
• Catalog Number: MD1-114545
• 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	10889981235581 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211606

FDA Product Code

• KWQ: Appliance, fixation, spinal intervertebral body

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[10889981235581]

Moist Heat or Steam Sterilization

[10889981235581]

Moist Heat or Steam Sterilization

[10889981235581]

Moist Heat or Steam Sterilization

[10889981235581]

Moist Heat or Steam Sterilization

[10889981235581]

Moist Heat or Steam Sterilization

[10889981235581]

Moist Heat or Steam Sterilization

[10889981235581]

Moist Heat or Steam Sterilization

[10889981235581]

Moist Heat or Steam Sterilization

[10889981235581]

Moist Heat or Steam Sterilization

[10889981235581]

Moist Heat or Steam Sterilization

[10889981235581]

Moist Heat or Steam Sterilization

[10889981235581]

Moist Heat or Steam Sterilization

[10889981235581]

Moist Heat or Steam Sterilization

[10889981235581]

Moist Heat or Steam Sterilization

[10889981235581]

Moist Heat or Steam Sterilization

[10889981235581]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-04-03
• Device Publish Date: 2023-03-24

On-Brand Devices [Mariner Deformity]

• 10889981256319: Tri-Flat Tap, 12.5mm
• 10889981256302: Tri-Flat Tap, 12.0mm
• 10889981256296: Tri-Flat Tap, 11.5mm
• 10889981256289: Tri-Flat Tap, 11.0mm
• 10889981256272: Tri-Flat Tap, 10.5mm
• 10889981256265: Tri-Flat Tap, 10.0mm
• 10889981256258: Tri-Flat Tap, 9.5mm
• 10889981256241: Tri-Flat Tap, 9.0mm
• 10889981256234: Tri-Flat Tap, 8.5mm
• 10889981256227: Tri-Flat Tap, 8.0mm
• 10889981256210: Tri-Flat Tap, 7.5mm
• 10889981256203: Tri-Flat Tap, 7.0mm
• 10889981256197: Tri-Flat Tap, 6.5mm
• 10889981256180: Tri-Flat Tap, 6.0mm
• 10889981256173: Tri-Flat Tap, 5.5mm
• 10889981256166: Tri-Flat Tap, 5.0mm
• 10889981256159: Tri-Flat Tap, 4.5mm
• 10889981256142: Tri-Flat Tap, 4.0mm
• 10889981256135: Tri-Flat Tap, 3.5mm
• 10889981256104: Tap, 12.0mm
• 10889981256098: Tap, 11.0mm
• 10889981256081: Tap, 10.0mm
• 10889981256074: Tap, 9.0mm
• 10889981256067: Tap, 8.0mm
• 10889981256050: Tap, 7.5mm
• 10889981256043: Tap, 7.0mm
• 10889981256036: Tap, 6.5mm
• 10889981256029: Tap, 6.0mm
• 10889981256012: Tap, 5.5mm
• 10889981256005: Tap, 5.0mm
• 10889981255992: Tap, 4.5mm
• 10889981255985: Tap, 4.0mm
• 10889981255978: Tap, 3.5mm
• 10889981255121: Tap, 12.5mm
• 10889981255114: Tap, 11.5mm
• 10889981255107: Tap, 10.5mm
• 10889981255091: Tap, 9.5mm
• 10889981255084: Tap, 8.5mm
• 10889981245016: Axial Reducer
• 10889981256111: Closed/Side Polyaxial Screwdriver
• 10889981235468: Polyaxial Head, Closed, Titanium
• 10889981276225: Mariner Deformity Fenestrated Screws
• 10889981276218: Injection Needle Caddy
• 10889981274214: Mariner Deformity Implant Set Insert 2
• 10889981274207: Mariner Deformity Implant Set Insert 1
• 10889981274191: Auxiliary Implant Base
• 10889981274177: Head Caddy
• 10889981274153: Fenestrated Screws, Cannulated
• 10889981274146: Fenestrated Screws, Solid
• 10889981274139: 7.5mm Uni-Axial Screws