Tether™ 03-10-0120

GUDID 10889981035426

Plate - 1 Level - 20mm

SEASPINE ORTHOPEDICS CORPORATION

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 10889981035426
• NIH Device Record Key: 5f5d0b4a-1015-4eff-b995-9c95277531e9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Tether™
• Version Model Number: 03-10-0120
• Catalog Number: 03-10-0120
• 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

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 Identifiers

Device Issuing Agency	Device ID
GS1	10889981035426 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K010466

FDA Product Code

• KWQ: APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Sterilization

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

[10889981035426]

Moist Heat or Steam Sterilization

[10889981035426]

Moist Heat or Steam Sterilization

[10889981035426]

Moist Heat or Steam Sterilization

[10889981035426]

Moist Heat or Steam Sterilization

[10889981035426]

Moist Heat or Steam Sterilization

[10889981035426]

Moist Heat or Steam Sterilization

[10889981035426]

Moist Heat or Steam Sterilization

[10889981035426]

Moist Heat or Steam Sterilization

[10889981035426]

Moist Heat or Steam Sterilization

[10889981035426]

Moist Heat or Steam Sterilization

[10889981035426]

Moist Heat or Steam Sterilization

[10889981035426]

Moist Heat or Steam Sterilization

[10889981035426]

Moist Heat or Steam Sterilization

[10889981035426]

Moist Heat or Steam Sterilization

[10889981035426]

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: 2015-09-24

On-Brand Devices [Tether™]

• 10889981036171: Screw - Self-Drilling - Variable - 4.0x16mm
• 10889981036164: Screw - Self-Drilling - Variable - 4.0x15mm
• 10889981036157: Screw - Self-Drilling - Variable - 4.0x14mm
• 10889981036140: Screw - Self-Drilling - Variable - 4.0x13mm
• 10889981036133: Screw - Self-Drilling - Variable - 4.0x12mm
• 10889981036126: Screw - Self-Drilling - Variable - 4.0x11mm
• 10889981036119: Screw - Self-Drilling - Variable - 4.0x10mm
• 10889981036102: Screw - Self-Drilling - Fixed - 4.0x16mm
• 10889981036096: Screw - Self-Drilling - Fixed - 4.0x15mm
• 10889981036089: Screw - Self-Drilling - Fixed - 4.0x14mm
• 10889981036072: Screw - Self-Drilling - Fixed - 4.0x13mm
• 10889981036065: Screw - Self-Drilling - Fixed - 4.0x12mm
• 10889981036058: Screw - Self-Drilling - Fixed - 4.0x11mm
• 10889981036041: Screw - Self-Drilling - Fixed - 4.0x10mm
• 10889981036034: Screw - Self-Tapping - Variable - 4.5x17mm
• 10889981036027: Screw - Self-Tapping - Variable - 4.5x15mm
• 10889981036010: Screw - Self-Tapping - Variable - 4.5x13mm
• 10889981036003: Screw - Self-Tapping - Variable - 4.0x20mm
• 10889981035990: Screw - Self-Tapping - Variable - 4.0x19mm
• 10889981035983: Screw - Self-Tapping - Variable - 4.0x18mm
• 10889981035976: Screw - Self-Tapping - Variable - 4.0x17mm
• 10889981035969: Screw - Self-Tapping - Variable - 4.0x16mm
• 10889981035952: Screw - Self-Tapping - Variable - 4.0x15mm
• 10889981035945: Screw - Self-Tapping - Variable - 4.0x14mm
• 10889981035938: Screw - Self-Tapping - Variable - 4.0x13mm
• 10889981035921: Screw - Self-Tapping - Variable - 4.0x12mm
• 10889981035914: Screw - Self-Tapping - Variable - 4.0x11mm
• 10889981035907: Screw - Self-Tapping - Variable - 4.0x10mm
• 10889981035891: Screw - Self-Tapping - Fixed - 4.5x17mm
• 10889981035884: Screw - Self-Tapping - Fixed - 4.5x15mm
• 10889981035877: Screw - Self-Tapping - Fixed - 4.5x13mm
• 10889981035860: Screw - Self-Tapping - Fixed - 4.0x20mm
• 10889981035853: Screw - Self-Tapping - Fixed - 4.0x19mm
• 10889981035846: Screw - Self-Tapping - Fixed - 4.0x18mm
• 10889981035839: Screw - Self-Tapping - Fixed - 4.0x17mm
• 10889981035822: Screw - Self-Tapping - Fixed - 4.0x16mm
• 10889981035815: Screw - Self-Tapping - Fixed - 4.0x15mm
• 10889981035808: Screw - Self-Tapping - Fixed - 4.0x14mm
• 10889981035792: Screw - Self-Tapping - Fixed - 4.0x13mm
• 10889981035785: Screw - Self-Tapping - Fixed - 4.0x12mm
• 10889981035778: Screw - Self-Tapping - Fixed - 4.0x11mm
• 10889981035761: Screw - Self-Tapping - Fixed - 4.0x10mm
• 10889981035754: Plate - 4 Level - 84mm
• 10889981035747: Plate - 4 Level - 80mm
• 10889981035730: Plate - 4 Level - 76mm
• 10889981035723: Plate - 4 Level - 72mm
• 10889981035716: Plate - 4 Level - 68mm
• 10889981035709: Plate - 4 Level - 64mm
• 10889981035693: Plate - 4 Level - 60mm
• 10889981035686: Plate - 3 Level - 67mm