Daytona® Small Stature 76-0313

GUDID 10889981152840

Ext. Axial Connector 2-Screw, 50mm, 3mm OZAT

SEASPINE ORTHOPEDICS CORPORATION

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile

• Primary Device ID: 10889981152840
• NIH Device Record Key: 39fc2a6d-2db9-4715-a6ae-602bfbf3cb3d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Daytona® Small Stature
• Version Model Number: 76-0313
• Catalog Number: 76-0313
• 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	10889981152840 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K193224

FDA Product Code

• PGM: Growing rod system

Sterilization

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

[10889981152840]

Moist Heat or Steam Sterilization

[10889981152840]

Moist Heat or Steam Sterilization

[10889981152840]

Moist Heat or Steam Sterilization

[10889981152840]

Moist Heat or Steam Sterilization

[10889981152840]

Moist Heat or Steam Sterilization

[10889981152840]

Moist Heat or Steam Sterilization

[10889981152840]

Moist Heat or Steam Sterilization

[10889981152840]

Moist Heat or Steam Sterilization

[10889981152840]

Moist Heat or Steam Sterilization

[10889981152840]

Moist Heat or Steam Sterilization

[10889981152840]

Moist Heat or Steam Sterilization

[10889981152840]

Moist Heat or Steam Sterilization

[10889981152840]

Moist Heat or Steam Sterilization

[10889981152840]

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

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