Mariner Cortical MC1-190035

GUDID 10889987169422

CORTICAL SHANK, Cannulated, 9.0 X 35

SEASPINE ORTHOPEDICS CORPORATION

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 10889987169422
• NIH Device Record Key: 910029e3-b4f1-4c4e-801c-bb940ee7bce5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mariner Cortical
• Version Model Number: MC1-190035
• Catalog Number: MC1-190035
• 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
• 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
• 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	10889987169422 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173882

FDA Product Code

• NKB: Thoracolumbosacral pedicle screw system

Sterilization

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

[10889987169422]

Moist Heat or Steam Sterilization

[10889987169422]

Moist Heat or Steam Sterilization

[10889987169422]

Moist Heat or Steam Sterilization

[10889987169422]

Moist Heat or Steam Sterilization

[10889987169422]

Moist Heat or Steam Sterilization

[10889987169422]

Moist Heat or Steam Sterilization

[10889987169422]

Moist Heat or Steam Sterilization

[10889987169422]

Moist Heat or Steam Sterilization

[10889987169422]

Moist Heat or Steam Sterilization

[10889987169422]

Moist Heat or Steam Sterilization

[10889987169422]

Moist Heat or Steam Sterilization

[10889987169422]

Moist Heat or Steam Sterilization

[10889987169422]

Moist Heat or Steam Sterilization

[10889987169422]

Moist Heat or Steam Sterilization

[10889987169422]

Moist Heat or Steam Sterilization

[10889987169422]

Moist Heat or Steam Sterilization

[10889987169422]

Moist Heat or Steam Sterilization

[10889987169422]

Moist Heat or Steam Sterilization

[10889987169422]

Moist Heat or Steam Sterilization

[10889987169422]

Moist Heat or Steam Sterilization

[10889987169422]

Moist Heat or Steam Sterilization

[10889987169422]

Moist Heat or Steam Sterilization

[10889987169422]

Moist Heat or Steam Sterilization

[10889987169422]

Moist Heat or Steam Sterilization

[10889987169422]

Moist Heat or Steam Sterilization

[10889987169422]

Moist Heat or Steam Sterilization

[10889987169422]

Moist Heat or Steam Sterilization

[10889987169422]

Moist Heat or Steam Sterilization

[10889987169422]

Moist Heat or Steam Sterilization

[10889987169422]

Moist Heat or Steam Sterilization

[10889987169422]

Moist Heat or Steam Sterilization

[10889987169422]

Moist Heat or Steam Sterilization

[10889987169422]

Moist Heat or Steam Sterilization

[10889987169422]

Moist Heat or Steam Sterilization

[10889987169422]

Moist Heat or Steam Sterilization

[10889987169422]

Moist Heat or Steam Sterilization

[10889987169422]

Moist Heat or Steam Sterilization

[10889987169422]

Moist Heat or Steam Sterilization

[10889987169422]

Moist Heat or Steam Sterilization

[10889987169422]

Moist Heat or Steam Sterilization

[10889987169422]

Moist Heat or Steam Sterilization

[10889987169422]

Moist Heat or Steam Sterilization

[10889987169422]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-02-11
• Device Publish Date: 2019-01-09

On-Brand Devices [Mariner Cortical]

• 10889987170305: Counter Torque, Slim
• 10889987170299: Compressor, Slim
• 10889987170282: Rod Measurement Wand
• 10889987170275: Slim Head Inserter, Long
• 10889987170268: Slim Head Inserter, Short
• 10889987170251: Slim Head Inserter
• 10889987170244: Face-cutting Reamer, T-Handle
• 10889987170237: Face-cutting Reamer, Tri-flat
• 10889987170220: Face-cutting Reamer, A/O
• 10889987170213: Face-cutting Reamer, 1/4"Quick-connect
• 10889987170206: 4.0mm Drill, Solid, Tri-Flat
• 10889987170190: 4.0mm Drill, Solid, A/O QC
• 10889987170183: 4.0mm Drill, Solid, 1/4" QC
• 10889987170176: 3.5mm Drill, Solid, Tri-Flat
• 10889987170169: 3.5mm Drill, Solid, A/O QC
• 10889987170152: 3.5mm Drill, Solid, 1/4" QC
• 10889987170145: 3.0mm Drill, Solid, Tri-Flat
• 10889987170138: 3.0mm Drill, Solid, A/O QC
• 10889987170121: 3.0mm Drill, Solid, 1/4" QC
• 10889987170114: Cortical Screw Shank Driver, Long
• 10889987170107: Cortical Screw Shank Driver, Short
• 10889987170091: Cortical Screw Shank Driver
• 10889987170084: 6.5mm Tap, Cortical, Cannulated
• 10889987170077: 6.0mm Tap, Cortical, Cannulated
• 10889987170060: 5.5mm Tap, Cortical, Cannulated
• 10889987170053: 5.0mm Tap, Cortical, Cannulated
• 10889987170046: 4.5mm Tap, Cortical, Cannulated
• 10889987170039: Adjustable Drill Guide
• 10889987170022: 6.5mm Tap, Cortical, Solid
• 10889987170015: 6.0mm Tap, Cortical, Solid
• 10889987170008: 5.5mm Tap, Cortical, Solid
• 10889987169996: 5.0mm Tap, Cortical, Solid
• 10889987169989: 4.5mm Tap, Cortical, Solid
• 10889987169972: 4.0mm Tap, Cortical, Solid
• 10889987169958: Constrained Rod, 120mm, Precontoured
• 10889987169941: Constrained Rod, 110mm, Precontoured
• 10889987169927: Constrained Rod, 95mm, Precontoured
• 10889987169910: Constrained Rod, 90mm, Precontoured
• 10889987169903: Constrained Rod, 85mm, Precontoured
• 10889987169880: Constrained Rod, 75mm, Precontoured
• 10889987169873: Constrained Rod, 70mm, Precontoured
• 10889987169866: Constrained Rod, 65mm, Precontoured
• 10889987169859: Constrained Rod, 60mm, Precontoured
• 10889987169842: Constrained Rod, 55mm, Precontoured
• 10889987169835: Constrained Rod, 50mm, Precontoured
• 10889987169811: Constrained Rod, 40mm, Precontoured
• 10889987169804: Constrained Rod, 35mm, Precontoured
• 10889987169798: Constrained Rod, 30mm, Precontoured
• 10889987169781: Constrained Rod, 25mm, Precontoured
• 10889987169774: Constrained Rod, 20mm, Precontoured