Daytona® Small Stature

Basic Information

• Brand Name: Daytona® Small Stature
• Primary DI: 10889981161828
• Version / Model: 76-0445
• Catalog Number: 76-0445
• Company Name: Seaspine Orthopedics Corporation
• Labeler DUNS: 079840876
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-19
• Public Version: 1
• Public Version Date: 2025-12-29
• Public Version Status: New
• Public Device Record Key: 35083feb-dc35-4eb0-9dc0-8f20651bcec2

Device Description

Laminar Ramped Hook, 6.5 x 5.5mm

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: Yes
• Sterilization Methods: Moist Heat or Steam Sterilization

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KWQ	Appliance, fixation, spinal intervertebral body	Orthopedic	888.3060	2
KWP	APPLIANCE, FIXATION, SPINAL INTERLAMINAL	Orthopedic	888.3050	2
NKB	Thoracolumbosacral pedicle screw system	Orthopedic	888.3070	2

GMDN Terms

Code	Name	Definition	Implantable	Status
65115	Bone-screw internal spinal fixation system hook	An implantable component of a bone-screw internal spinal fixation system that has a curved (hook-shaped) design intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is typically made of metal [e.g., titanium (Ti)] and placed/hooked around the lamina or pedicle of a vertebra, without penetration (i.e., not a screw), to provide a stable connection for the system’s rod; the rod is typically stabilized in the U-shaped hook head with a small lid or screw.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10889981161828	GS1

Premarket Submissions

Submission Number	Supplement Number
K200381	000