Fathom MR2-104100

GUDID 10889981300326

Mariner MIS Head Inserter

SEASPINE ORTHOPEDICS CORPORATION

Orthopaedic implant inserter/extractor, reusable

• Primary Device ID: 10889981300326
• NIH Device Record Key: c7a2abaa-cd40-47fc-acfc-dd2c8124de3b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Fathom
• Version Model Number: MR2-104100
• Catalog Number: MR2-104100
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981300326 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K191648

FDA Product Code

• KWQ: Appliance, fixation, spinal intervertebral body

Sterilization

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

[10889981300326]

Moist Heat or Steam Sterilization

[10889981300326]

Moist Heat or Steam Sterilization

[10889981300326]

Moist Heat or Steam Sterilization

[10889981300326]

Moist Heat or Steam Sterilization

[10889981300326]

Moist Heat or Steam Sterilization

[10889981300326]

Moist Heat or Steam Sterilization

[10889981300326]

Moist Heat or Steam Sterilization

[10889981300326]

Moist Heat or Steam Sterilization

[10889981300326]

Moist Heat or Steam Sterilization

[10889981300326]

Moist Heat or Steam Sterilization

[10889981300326]

Moist Heat or Steam Sterilization

[10889981300326]

Moist Heat or Steam Sterilization

[10889981300326]

Moist Heat or Steam Sterilization

[10889981300326]

Moist Heat or Steam Sterilization

[10889981300326]

Moist Heat or Steam Sterilization

[10889981300326]

Moist Heat or Steam Sterilization

[10889981300326]

Moist Heat or Steam Sterilization

[10889981300326]

Moist Heat or Steam Sterilization

[10889981300326]

Moist Heat or Steam Sterilization

[10889981300326]

Moist Heat or Steam Sterilization

[10889981300326]

Moist Heat or Steam Sterilization

[10889981300326]

Moist Heat or Steam Sterilization

[10889981300326]

Moist Heat or Steam Sterilization

[10889981300326]

Moist Heat or Steam Sterilization

[10889981300326]

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 [Fathom]

• 10889981306830: Lamina Cobb
• 10889981300326: Mariner MIS Head Inserter
• 10889981300319: Medial Extension Arm, Long, Right
• 10889981300302: Medial Extension Arm, Long, Left
• 10889981300296: Medial Extension Arm, Small, Right
• 10889981300289: Medial Extension Arm, Small, Left
• 10889981300272: Alignment Clip, Disposable
• 10889981300265: Mariner MIS Navigation Shank Driver
• 10889981300258: Retractor Base Rack, 170mm
• 10889981300241: Retractor Base Rack, 135mm
• 10889981300180: Table Arm
• 10889981300173: Retractor Base Arm, Right
• 10889981300166: Retractor Base Arm, Left
• 10889981300159: Medial Blade Inserter
• 10889981300111: Medial Blade, 75-115mm
• 10889981300104: Medial Blade, 50-80mm
• 10889981300098: Medial Blade, 35-55mm
• 10889981300081: C/C Blade, 110-140mm
• 10889981300074: C/C Blade, 75-115mm
• 10889981300067: C/C Blade, 50-80mm
• 10889981300050: C/C Blade, 35-55mm