Skip to content

Daytona Anterior Cervical Cage

by Spinenet, LLC

510(k) K110733

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK110733 Date25 Aug 2011ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2103-2013 FDA Class II initiated 5 Feb 2013

    The recall decision has been made because because it has recently been determined that the instructions for use (IFU) had certain statements that should have been removed prior to initial product marketing.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
ODP
Device Class
Class II
Regulation
21 CFR Part 888.3080
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Daytona Anterior Cervical Cage is an intracorporeal implant for anterior cervical spondylodesis, designed to reproduce a tri-cortical iliac crest bone graft in PEEK material and provide structural support as an interbody spacer for anterior cervical fusions. It features a wedge-shaped design with surface teeth to prevent migration and allows for intimate contact with endplate surfaces for optimum stability and to resist subsidence.

The device is implanted via anterior approach at C2-T1 levels to maintain disc space and facilitate fusion, requiring autograft bone and supplemental fixation. The Daytona Anterior Cervical Cage is supplied as a sterile device and is intended for single use. It has received FDA 510(k) clearance with the product code ODP and is indicated for use in anterior cervical fusions.

Other devices from SpineNet LLC

See all devices from SpineNet LLC →

Questions

AI-generated answers, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Daytona Anterior Cervical Cage used for?

    The Daytona Anterior Cervical Cage is an intracorporeal implant designed for anterior cervical spondylodesis. It serves as an interbody spacer to maintain disc space and facilitate fusion at C2-T1 levels in the cervical spine.

  • How is the Daytona Anterior Cervical Cage implanted?

    The device is implanted via an anterior approach and requires autograft bone and supplemental fixation. Its wedge-shaped design with surface teeth prevents migration and provides intimate contact with endplate surfaces for optimum stability and resistance to subsidence.

  • Is the Daytona Anterior Cervical Cage reusable or single-use?

    The Daytona Anterior Cervical Cage is supplied as a sterile device and is intended for single use only. It should not be reused or resterilized for patient safety and regulatory compliance.

  • What material is the Daytona Anterior Cervical Cage made from?

    The Daytona Anterior Cervical Cage is made from PEEK (polyetheretherketone) material, which is designed to reproduce a tri-cortical iliac crest bone graft while providing structural support as an interbody spacer for anterior cervical fusions.

  • What regulatory clearance has the Daytona Anterior Cervical Cage received?

    The Daytona Anterior Cervical Cage has received FDA 510(k) clearance with the product code ODP. It is indicated for use in anterior cervical fusions and was determined to be substantially equivalent to predicate devices.