Daytona® Small Stature 79-0324

GUDID 10889981185879

Fixed Crossbar, 4.5mm x 24mm, 3mm OZAT

SEASPINE ORTHOPEDICS CORPORATION

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 10889981185879
• NIH Device Record Key: f59b477c-b9f3-4948-b7c4-dace3a78c840
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Daytona® Small Stature
• Version Model Number: 79-0324
• Catalog Number: 79-0324
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981185879 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200381

FDA Product Code

• KWQ: Appliance, fixation, spinal intervertebral body

Sterilization

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

[10889981185879]

Moist Heat or Steam Sterilization

[10889981185879]

Moist Heat or Steam Sterilization

[10889981185879]

Moist Heat or Steam Sterilization

[10889981185879]

Moist Heat or Steam Sterilization

[10889981185879]

Moist Heat or Steam Sterilization

[10889981185879]

Moist Heat or Steam Sterilization

[10889981185879]

Moist Heat or Steam Sterilization

[10889981185879]

Moist Heat or Steam Sterilization

[10889981185879]

Moist Heat or Steam Sterilization

[10889981185879]

Moist Heat or Steam Sterilization

[10889981185879]

Moist Heat or Steam Sterilization

[10889981185879]

Moist Heat or Steam Sterilization

[10889981185879]

Moist Heat or Steam Sterilization

[10889981185879]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-08-20
• Device Publish Date: 2020-08-12

On-Brand Devices [Daytona® Small Stature]

• 10889981217396: Sm Stat Hooks, Conn Tray, Axial Conn Caddy
• 10889981230715: Cann Uni-Planar Screw, 7.5 x 70mm, Sm Stat
• 10889981230708: Cann Uni-Planar Screw, 7.5 x 65mm, Sm Stat
• 10889981230692: Cann Uni-Planar Screw, 6.5 x 70mm, Sm Stat
• 10889981230685: Cann Uni-Planar Screw, 6.5 x 65mm, Sm Stat
• 10889981212315: Box Wrench
• 10889981212308: Derotation Sleeve, Short, Small Stature
• 10889981212292: Derotation Tube, Short, Small Stature
• 10889981212285: Derotation Sleeve, Long, Small Stature
• 10889981212278: Derotation Tube, Long, Small Stature
• 10889981212254: Extended Axial Connector, Screw, 3mm OZAT
• 10889981212063: Small Stature Uni Tray, Level 1
• 10889981212056: Small Stature Uni Tray, Screw Caddy
• 10889981212049: Small Stature Uni Tray, Base
• 10889981187620: Solid Polyaxial Screw, 7.5 x 95mm, Sm Stat
• 10889981187613: Solid Polyaxial Screw, 7.5 x 90mm, Sm Stat
• 10889981187606: Solid Polyaxial Screw, 7.5 x 85mm, Sm Stat
• 10889981187590: Solid Polyaxial Screw, 7.5 x 80mm, Sm Stat
• 10889981187583: Solid Polyaxial Screw, 7.5 x 75mm, Sm Stat
• 10889981187576: Solid Polyaxial Screw, 7.5 x 60mm, Sm Stat
• 10889981187569: Solid Polyaxial Screw, 7.5 x 55mm, Sm Stat
• 10889981187552: Solid Polyaxial Screw, 7.5 x 50mm, Sm Stat
• 10889981187545: Solid Polyaxial Screw, 7.5 x 45mm, Sm Stat
• 10889981187538: Solid Polyaxial Screw, 7.5 x 40mm, Sm Stat
• 10889981187521: Solid Polyaxial Screw, 7.5 x 35mm, Sm Stat
• 10889981187514: Solid Polyaxial Screw, 7.5 x 30mm, Sm Stat
• 10889981187491: Solid Polyaxial Screw, 7.5 x 110mm, Sm Stat
• 10889981187484: Solid Polyaxial Screw, 7.5 x 105mm, Sm Stat
• 10889981187477: Solid Polyaxial Screw, 7.5 x 100mm, Sm Stat
• 10889981187460: Solid Polyaxial Screw, 6.5 x 95mm, Sm Stat
• 10889981187453: Solid Polyaxial Screw, 6.5 x 90mm, Sm Stat
• 10889981187446: Solid Polyaxial Screw, 6.5 x 85mm, Sm Stat
• 10889981187439: Solid Polyaxial Screw, 6.5 x 80mm, Sm Stat
• 10889981187422: Solid Polyaxial Screw, 6.5 x 75mm, Sm Stat
• 10889981187415: Solid Polyaxial Screw, 6.5 x 60mm, Sm Stat
• 10889981187408: Solid Polyaxial Screw, 6.5 x 55mm, Sm Stat
• 10889981187392: Solid Polyaxial Screw, 6.5 x 50mm, Sm Stat
• 10889981187385: Solid Polyaxial Screw, 6.5 x 45mm, Sm Stat
• 10889981187378: Solid Polyaxial Screw, 6.5 x 40mm, Sm Stat
• 10889981187361: Solid Polyaxial Screw, 6.5 x 35mm, Sm Stat
• 10889981187354: Solid Polyaxial Screw, 6.5 x 30mm, Sm Stat
• 10889981187347: Solid Polyaxial Screw, 6.5 x 25mm, Sm Stat
• 10889981187323: Solid Polyaxial Screw, 6.5 x 110mm, Sm Stat
• 10889981187316: Solid Polyaxial Screw, 6.5 x 105mm, Sm Stat
• 10889981187309: Solid Polyaxial Screw, 6.5 x 100mm, Sm Stat
• 10889981187293: Solid Polyaxial Screw, 6.0 x 60mm, Sm Stat
• 10889981187286: Solid Polyaxial Screw, 6.0 x 55mm, Sm Stat
• 10889981187279: Solid Polyaxial Screw, 6.0 x 50mm, Sm Stat
• 10889981187262: Solid Polyaxial Screw, 6.0 x 45mm, Sm Stat
• 10889981187255: Solid Polyaxial Screw, 6.0 x 40mm, Sm Stat