Mariner 41-1525-4

GUDID 10889981073381

Fixed Screw 10.50 x 25mm

SEASPINE ORTHOPEDICS CORPORATION

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 10889981073381
• NIH Device Record Key: f1e52a6f-ead3-42db-9705-89f879302875
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mariner
• Version Model Number: 41-1525-4
• Catalog Number: 41-1525-4
• 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

Device Dimensions

• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981073381 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K160902

FDA Product Code

• NKB: Orthosis, spinal pedicle fixation, for degenerative disc disease

Sterilization

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

[10889981073381]

Moist Heat or Steam Sterilization

[10889981073381]

Moist Heat or Steam Sterilization

[10889981073381]

Moist Heat or Steam Sterilization

[10889981073381]

Moist Heat or Steam Sterilization

[10889981073381]

Moist Heat or Steam Sterilization

[10889981073381]

Moist Heat or Steam Sterilization

[10889981073381]

Moist Heat or Steam Sterilization

[10889981073381]

Moist Heat or Steam Sterilization

[10889981073381]

Moist Heat or Steam Sterilization

[10889981073381]

Moist Heat or Steam Sterilization

[10889981073381]

Moist Heat or Steam Sterilization

[10889981073381]

Moist Heat or Steam Sterilization

[10889981073381]

Moist Heat or Steam Sterilization

[10889981073381]

Moist Heat or Steam Sterilization

[10889981073381]

Moist Heat or Steam Sterilization

[10889981073381]

Moist Heat or Steam Sterilization

[10889981073381]

Moist Heat or Steam Sterilization

[10889981073381]

Moist Heat or Steam Sterilization

[10889981073381]

Moist Heat or Steam Sterilization

[10889981073381]

Moist Heat or Steam Sterilization

[10889981073381]

Moist Heat or Steam Sterilization

[10889981073381]

Moist Heat or Steam Sterilization

[10889981073381]

Moist Heat or Steam Sterilization

[10889981073381]

Moist Heat or Steam Sterilization

[10889981073381]

Moist Heat or Steam Sterilization

[10889981073381]

Moist Heat or Steam Sterilization

[10889981073381]

Moist Heat or Steam Sterilization

[10889981073381]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-02

On-Brand Devices [Mariner]

• 10889998163471: Mariner 6.0 Tray, Insert 2
• 10889997163465: Mariner 6.0 Tray, Insert 1
• 10889996163459: Mariner 6.0 Tray, Base
• 10889995163443: Sagittal Benders (R) 5.5
• 10889994163437: Sagittal Benders (L) 5.5
• 10889993163421: Coronal Bender (R) 5.5
• 10889992163415: Coronal Benders (L) 5.5
• 10889991163409: Sagittal Bender (R) 6.0
• 10889990163394: Sagittal Benders (L) 6.0
• 10889989163381: Coronal Benders (R) 6.0
• 10889988164730: Rod Gripper 5.5/6.0
• 10889988163375: Coronal Benders (L) 6.0
• 10889987163345: 5.5mm X 500mm Rod Template
• 10889987163338: Hex End Rod Rotator 5.5/6.0
• 10889981160050: Adjustable Pedicle Screw Driver, Locking, 1/4 Sq
• 10889981160043: Pedicle Screw Driver, Locking, Tri-Flat
• 10889981160036: Pedicle Screw Driver, Locking, 1/4 sq
• 10889981160029: Extended Trauma Head
• 10889981160012: Extended Deformity Head
• 10889981160005: Extended Polyaxial Head
• 10889981155131: Trauma Head
• 10889981155124: Deformity Head
• 10889981155117: Polyaxial Head
• 10889981155100: Set Screw
• 10889981149833: Mariner Quick Release Reducer
• 10889981148195: Precontoured CoCr Rod, 5.5 x 75mm
• 10889981148188: Precontoured CoCr Rod, 5.5 x 65mm
• 10889981148171: Precontoured CoCr Rod, 5.5 x 55mm
• 10889981148164: Precontoured CoCr Rod, 5.5 x 45mm
• 10889981148157: Precontoured CoCr Rod, 6.0 x 75mm
• 10889981148140: Precontoured CoCr Rod, 6.0 x 65mm
• 10889981148133: Precontoured CoCr Rod, 6.0 x 55mm
• 10889981148126: Precontoured CoCr Rod, 6.0 x 45mm
• 10889981148102: Precontoured ESS Plus Rod, 6.0 x 65mm
• 10889981148096: Precontoured ESS Plus Rod, 6.0 x 55mm
• 10889981148089: Precontoured ESS Plus Rod, 6.0 x 45mm
• 10889981148072: Precontoured ESS Rod, 6.0 x 75mm
• 10889981148065: Precontoured ESS Rod, 6.0 x 65mm
• 10889981148058: Precontoured ESS Rod, 6.0 x 55mm
• 10889981148041: Precontoured ESS Rod, 6.0 x 45mm
• 10889981147990: Contoured Crossbar, Large, 6.0 Rod
• 10889981147983: Contoured Crossbar, Medium, 6.0 Rod
• 10889981147976: Contoured Crossbar, Small, 6.0 Rod
• 10889981147969: Precontoured CoCr Rod, 6.0 x 600mm
• 10889981147952: Precontoured CoCr Rod, 6.0 x 550mm
• 10889981147945: Precontoured CoCr Rod, 6.0 x 500mm
• 10889981147938: Precontoured CoCr Rod, 6.0 x 450mm
• 10889981147921: Precontoured CoCr Rod, 6.0 x 400mm
• 10889981147914: Precontoured CoCr Rod, 6.0 x 350mm
• 10889981147907: Precontoured CoCr Rod, 6.0 x 300mm