Daytona Small Stature 76-0214

GUDID 10889981152611

Fixed Crossbar, 4.5 x 14mm

SEASPINE ORTHOPEDICS CORPORATION

Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 10889981152611
• NIH Device Record Key: 3f3a8460-9396-4a1e-93bb-2f31448ccdb2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Daytona Small Stature
• Version Model Number: 76-0214
• Catalog Number: 76-0214
• 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

Device Dimensions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	10889981152611 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180686

FDA Product Code

• NKB: Thoracolumbosacral pedicle screw system

Sterilization

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

[10889981152611]

Moist Heat or Steam Sterilization

[10889981152611]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2018-07-24
• Device Publish Date: 2018-06-23

On-Brand Devices [Daytona Small Stature]

• 10889985163101: Sm Stat Hooks, Conn Tray, Axial Conn Caddy
• 10889985163095: Axial Hook Inserter Sleeve
• 10889981161293: Connector Set Screw, Replacement
• 10889981156770: Laminar Hook, 12.0 x 8.0mm
• 10889981156763: Laminar Hook, 12.0 x 6.5mm
• 10889981156756: Laminar Hook, 12.0 x 12.0mm
• 10889981156749: Laminar Hook, 12.0 x 10.0mm
• 10889981156732: Laminar Hook, 10.0 x 8.0mm
• 10889981156725: Laminar Hook, 10.0 x 6.5mm
• 10889981156718: Laminar Hook, 10.0 x 5.5mm
• 10889981156701: Laminar Hook, 10.0 x 10.0mm
• 10889981155346: Laminar Hook, 5.25 x 8.0mm
• 10889981155339: Laminar Hook, 5.25 x 6.5mm
• 10889981155322: Laminar Hook, 5.25 x 5.5mm
• 10889981155315: Laminar Hook, 5.25 x 4.25mm
• 10889981155308: Laminar Hook, 8.0 x 8.0mm
• 10889981155292: Laminar Hook, 8.0 x 6.5mm
• 10889981155285: Laminar Hook, 8.0 x 5.5mm
• 10889981155278: Laminar Hook, 8.0 x 4.25mm
• 10889981155261: Offset Hook, 4.0 x 8.0mm, Right
• 10889981155254: Offset Hook, 4.0 x 8.0mm, Left
• 10889981155247: Angled Hook, 4.0 x 8.0mm, Right
• 10889981155230: Angled Hook, 4.0 x 8.0mm, Left
• 10889981153199: Sm Stat Hooks, Conn Tray, CrossBar Caddy
• 10889981153182: Sm Stat Hooks, Conn Tray, Ext Axial Conn Caddy
• 10889981153168: Sm Stat Hooks, Conn Tray, Level 2
• 10889981153151: Sm Stat Hooks, Conn Tray, Add Hook Caddy
• 10889981153144: Sm Stat Hooks, Conn Tray, Asst Hook Caddy
• 10889981153137: Sm Stat Hooks, Conn Tray, Lam Hook Caddy
• 10889981153120: Sm Stat Hooks, Conn Tray, Level 1
• 10889981153113: Sm Stat Hooks, Conn Tray, Base
• 10889981153106: 4mm Driver, Tri-Flat, Small Stature
• 10889981153090: Tap 8.0mm, Tri-Flat, Cannulated (for 8.5mm Screw)
• 10889981153083: Tap 7.5mm, Tri-Flat, Cannulated (for 8.0mm Screw)
• 10889981153076: Tap 7.0mm, Tri-Flat, Cannulated (for 7.5mm Screw)
• 10889981153069: Tap 6.5mm, Tri-Flat, Cannulated (for 7.0mm Screw)
• 10889981153052: Tap 6.0mm, Tri-Flat, Cannulated (for 6.5mm Screw)
• 10889981153045: Tap 5.5mm, Tri-Flat, Cannulated (for 6.0mm Screw)
• 10889981153038: Tap 5.0mm, Tri-Flat, Cannulated (for 5.5mm Screw)
• 10889981153021: Tap 4.5mm, Tri-Flat, Cannulated (for 5.0mm Screw)
• 10889981153014: Tap 4.0mm, Tri-Flat, Cannulated (for 4.5mm Screw)
• 10889981153007: Locking Driver Shaft, Tri-Flat, Small Stature
• 10889981152987: Fixed CrossBar Sizing Tool, Small Stature
• 10889981152970: Fixed CrossBar Contouring Handle, Right, Sm Stat
• 10889981152963: Fixed CrossBar Contouring Handle, Left, Sm Stat
• 10889981152956: Fixed CrossBar Inserter, Small Stature
• 10889981152949: Axial Hook Inserter, Shaft, Small Stature
• 10889981152932: Pedicle Finder, Small Stature
• 10889981152925: Lamina/Transverse Process Finder, Small Stature
• 10889981152918: Hook Pusher, Small Stature