Cabo 81-1316

GUDID 10889981160777

16mm

SEASPINE ORTHOPEDICS CORPORATION

Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 10889981160777
• NIH Device Record Key: 46d318e7-63fb-44b0-9aaa-1ce39eac9e12
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cabo
• Version Model Number: 81-1316
• Catalog Number: 81-1316
• 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

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	10889981160777 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K173521

FDA Product Code

• KWQ: Appliance, fixation, spinal intervertebral body

Sterilization

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

[10889981160777]

Moist Heat or Steam Sterilization

[10889981160777]

Moist Heat or Steam Sterilization

[10889981160777]

Moist Heat or Steam Sterilization

[10889981160777]

Moist Heat or Steam Sterilization

[10889981160777]

Moist Heat or Steam Sterilization

[10889981160777]

Moist Heat or Steam Sterilization

[10889981160777]

Moist Heat or Steam Sterilization

[10889981160777]

Moist Heat or Steam Sterilization

[10889981160777]

Moist Heat or Steam Sterilization

[10889981160777]

Moist Heat or Steam Sterilization

[10889981160777]

Moist Heat or Steam Sterilization

[10889981160777]

Moist Heat or Steam Sterilization

[10889981160777]

Moist Heat or Steam Sterilization

[10889981160777]

Moist Heat or Steam Sterilization

[10889981160777]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-04-17

On-Brand Devices [Cabo]

• 10889981160968: Temporary Fixation Pin
• 10889981160937: Variable -4.0mm Self Drilling, 18mm
• 10889981160920: Variable -4.0mm Self Drilling, 16mm
• 10889981160913: Variable -4.0mm Self Drilling, 14mm
• 10889981160906: Variable -4.0mm Self Drilling, 12mm
• 10889981160890: Variable -4.0mm Self Drilling, 10mm
• 10889981160883: Fixed -4.0mm Self Drilling, 18mm
• 10889981160876: Fixed -4.0mm Self Drilling, 16mm
• 10889981160869: Fixed -4.0mm Self Drilling, 14mm
• 10889981160852: Fixed -4.0mm Self Drilling, 12mm
• 10889981160845: Fixed -4.0mm Self Drilling, 10mm
• 10889981160838: Variable -4.5mm Self Tapping, 18mm
• 10889981160821: Variable -4.5mm Self Tapping, 16mm
• 10889981160814: Variable -4.5mm Self Tapping, 14mm
• 10889981160807: Variable -4.5mm Self Tapping, 12mm
• 10889981160791: Variable -4.5mm Self Tapping, 10mm
• 10889981160784: 18mm
• 10889981160777: 16mm
• 10889981160760: 14mm
• 10889981160753: 12mm
• 10889981160746: 10mm
• 10889981160739: Variable -4.0mm Self Tapping, 18mm
• 10889981160722: Variable -4.0mm Self Tapping, 16mm
• 10889981160715: Variable -4.0mm Self Tapping, 14mm
• 10889981160708: Variable -4.0mm Self Tapping, 12mm
• 10889981160692: Variable -4.0mm Self Tapping, 10mm
• 10889981160685: Fixed -4.0mm Self Tapping, 18mm
• 10889981160678: Fixed -4.0mm Self Tapping, 16mm
• 10889981160661: Fixed -4.0mm Self Tapping, 14mm
• 10889981160654: Fixed -4.0mm Self Tapping, 12mm
• 10889981160647: Fixed -4.0mm Self Tapping, 10mm
• 10889981160630: 5 Level Plate, 100mm
• 10889981160623: 5 Level Plate, 95mm
• 10889981160616: 5 Level Plate, 90mm
• 10889981160609: 5 Level Plate, 85mm
• 10889981160593: 4 Level Plate, 84mm
• 10889981160586: 4 Level Plate, 80mm
• 10889981160579: 4 Level Plate, 76mm
• 10889981160562: 4 Level Plate, 72mm
• 10889981160555: 4 Level Plate, 68mm
• 10889981160548: 4 Level Plate, 64mm
• 10889981160531: 3 Level Plate, 69mm
• 10889981160524: 3 Level Plate, 66mm
• 10889981160517: 3 Level Plate, 63mm
• 10889981160500: 3 Level Plate, 60mm
• 10889981160494: 3 Level Plate, 57mm
• 10889981160487: 3 Level Plate, 54mm
• 10889981160470: 3 Level Plate, 51mm
• 10889981160463: 3 Level Plate, 48mm
• 10889981160456: 3 Level Plate, 45mm