Cordant 26-07-0243

GUDID 10889981115241

43mm

SEASPINE ORTHOPEDICS CORPORATION

Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable Spinal fixation plate, non-bioabsorbable

• Primary Device ID: 10889981115241
• NIH Device Record Key: 5284d8da-4d78-446e-b7eb-ac66ffb7658d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cordant
• Version Model Number: 26-07-0243
• Catalog Number: 26-07-0243
• 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	10889981115241 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072650

FDA Product Code

• KWQ: Appliance, fixation, spinal intervertebral body

Sterilization

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

[10889981115241]

Moist Heat or Steam Sterilization

[10889981115241]

Moist Heat or Steam Sterilization

[10889981115241]

Moist Heat or Steam Sterilization

[10889981115241]

Moist Heat or Steam Sterilization

[10889981115241]

Moist Heat or Steam Sterilization

[10889981115241]

Moist Heat or Steam Sterilization

[10889981115241]

Moist Heat or Steam Sterilization

[10889981115241]

Moist Heat or Steam Sterilization

[10889981115241]

Moist Heat or Steam Sterilization

[10889981115241]

Moist Heat or Steam Sterilization

[10889981115241]

Moist Heat or Steam Sterilization

[10889981115241]

Moist Heat or Steam Sterilization

[10889981115241]

Moist Heat or Steam Sterilization

[10889981115241]

Moist Heat or Steam Sterilization

[10889981115241]

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: 2018-04-18

On-Brand Devices [Cordant]

• 10889981137090: Lid
• 10889981137083: 4 Level Plate Caddy
• 10889981137076: 3 Level Plate caddy
• 10889981137069: 1 & 2 Level Plate caddy
• 10889981137052: Screw Caddy
• 10889981137045: Implant Tray
• 10889981137038: Instrument Tray
• 10889981137021: Base
• 10889981121433: Case
• 10889981115623: Drill - 16mm (07-6007)
• 10889981115616: Drill - 14mm (07-6006)
• 10889981115609: Drill - 12mm (07-6005)
• 10889981115593: Plate Sizing Guide (07-7000)
• 10889981115586: Plate Bender (07-6700)
• 10889981115579: Tap (07-6600)
• 10889981115562: Double Barrel Limited Angle Drill Guide
• 10889981115555: Double Barrel Drill Guide (07-6500)
• 10889981115548: Single Barrel Limited Angle Drill Guide
• 10889981115531: Single Barrel Drill Guide (07-6400)
• 10889981115524: Spring Loaded Awl
• 10889981115517: Awl (07-6300)
• 10889981115500: AO Drill Driver (07-6200)
• 10889981115494: Screwdriver - NonTapered Split Tipped StarDrive
• 10889981115487: Screwdriver - Non-Tapered StarDrive
• 10889981115470: Screwdriver - StarDrive (07-6100)
• 10889981115463: Plate Holder (07-6012)
• 10889981115456: Temporary Fixation Pin (07-6004)
• 10889981115449: 93mm
• 10889981115432: 89mm
• 10889981115425: 85mm
• 10889981115418: 81mm
• 10889981115401: 77mm
• 10889981115395: 73mm
• 10889981115388: 69mm
• 10889981115371: 78mm
• 10889981115364: 75mm
• 10889981115357: 72mm
• 10889981115340: 69mm
• 10889981115333: 66mm
• 10889981115326: 63mm
• 10889981115319: Plate - 3 Level - 60mm (07-0360)
• 10889981115302: 57mm
• 10889981115296: 54mm
• 10889981115289: 55mm
• 10889981115272: 52mm
• 10889981115265: 49mm
• 10889981115258: 46mm
• 10889981115241: 43mm
• 10889981115234: 40mm
• 10889981115227: 37mm