Mariner MIS MM1-156075

GUDID 10889981217716

MIS PRECONTOURED ROD, 6.0 x 75MM

SEASPINE ORTHOPEDICS CORPORATION

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 10889981217716
• NIH Device Record Key: aa1d570e-3455-44ef-98aa-ef7f51e020fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mariner MIS
• Version Model Number: MM1-156075
• Catalog Number: MM1-156075
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981217716 [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

[10889981217716]

Moist Heat or Steam Sterilization

[10889981217716]

Moist Heat or Steam Sterilization

[10889981217716]

Moist Heat or Steam Sterilization

[10889981217716]

Moist Heat or Steam Sterilization

[10889981217716]

Moist Heat or Steam Sterilization

[10889981217716]

Moist Heat or Steam Sterilization

[10889981217716]

Moist Heat or Steam Sterilization

[10889981217716]

Moist Heat or Steam Sterilization

[10889981217716]

Moist Heat or Steam Sterilization

[10889981217716]

Moist Heat or Steam Sterilization

[10889981217716]

Moist Heat or Steam Sterilization

[10889981217716]

Moist Heat or Steam Sterilization

[10889981217716]

Moist Heat or Steam Sterilization

[10889981217716]

Moist Heat or Steam Sterilization

[10889981217716]

Moist Heat or Steam Sterilization

[10889981217716]

Moist Heat or Steam Sterilization

[10889981217716]

Moist Heat or Steam Sterilization

[10889981217716]

Moist Heat or Steam Sterilization

[10889981217716]

Moist Heat or Steam Sterilization

[10889981217716]

Moist Heat or Steam Sterilization

[10889981217716]

Moist Heat or Steam Sterilization

[10889981217716]

Moist Heat or Steam Sterilization

[10889981217716]

Moist Heat or Steam Sterilization

[10889981217716]

Moist Heat or Steam Sterilization

[10889981217716]

Moist Heat or Steam Sterilization

[10889981217716]

Moist Heat or Steam Sterilization

[10889981217716]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-07-28
• Device Publish Date: 2020-07-20

On-Brand Devices [Mariner MIS]

• 10889981213688: Handle
• 10889981230647: Fascial Blade Caddy
• 10889981221188: Mariner MIS Navigation Tray, Level 1
• 10889981221171: Mariner MIS Navigation Tray
• 10889981221164: MIS 6.0 Rod Caddy
• 10889981221157: MIS Set Screw Caddy
• 10889981221140: MIS 6.0 Constrained Rod Caddy
• 10889981221133: MIS Head Caddy
• 10889981221126: MIS Rod Caddy
• 10889981221119: Mariner MIS Implant Tray, Level 2
• 10889981221102: Mariner MIS Implant Tray, Level 1
• 10889981221096: Mariner MIS Implant Tray
• 10889981221089: Mariner MIS Instrument Tray 2, Level 2
• 10889981221072: Mariner MIS Instrument Tray 2, Level 1
• 10889981221065: Mariner MIS Instrument Tray 2
• 10889981221058: Mariner MIS Instrument Tray 1, Level 2
• 10889981221041: Mariner MIS Instrument Tray 1, Level 1
• 10889981221034: Mariner MIS Instrument Tray 1
• 10889981218546: CD Main Arm
• 10889981218539: CD Extended Tab Arm
• 10889981218522: CD Tower Arm
• 10889981218515: CD Driver
• 10889981218492: MIS Straight Rod, 6.0 x 450MM
• 10889981218485: MIS Straight Rod, 6.0 x 400MM
• 10889981218478: MIS Straight Rod, 6.0 x 350MM
• 10889981218461: MIS Straight Rod, 6.0 x 300MM
• 10889981218454: MIS Straight Rod, 6.0 x 250MM
• 10889981218447: MIS Straight Rod, 6.0 x 240MM
• 10889981218430: MIS Straight Rod, 6.0 x 230MM
• 10889981218423: MIS Straight Rod, 6.0 x 220MM
• 10889981218416: MIS Straight Rod, 6.0 x 210MM
• 10889981218409: MIS Straight Rod, 6.0 x 200MM
• 10889981218393: MIS Straight Rod, 6.0 x 190MM
• 10889981218386: MIS Straight Rod, 6.0 x 180MM
• 10889981218379: MIS Straight Rod, 6.0 x 170MM
• 10889981218362: MIS Straight Rod, 6.0 x 160MM
• 10889981218355: MIS Straight Rod, 6.0 x 150MM
• 10889981218348: MIS Straight Rod, 6.0 x 140MM
• 10889981218331: MIS Straight Rod, 6.0 x 130MM
• 10889981218324: MIS Straight Rod, 6.0 x 120MM
• 10889981218317: MIS Straight Rod, 6.0 x 110MM
• 10889981218300: MIS Straight Rod, 6.0 x 100MM
• 10889981218294: MIS Straight Rod, 6.0 x 95MM
• 10889981218287: MIS Straight Rod, 6.0 x 90MM
• 10889981218270: MIS Straight Rod, 6.0 x 85MM
• 10889981218263: MIS Straight Rod, 6.0 x 80MM
• 10889981218256: MIS Straight Rod, 6.0 x 75MM
• 10889981218249: MIS Straight Rod, 6.0 x 70MM
• 10889981218232: MIS Straight Rod, 6.0 x 65MM
• 10889981218225: MIS Straight Rod, 6.0 x 60MM