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DALI Spinal Fixation System

by Accel Spine

510(k) K121568

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

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 NumberK121568 Date21 Sep 2012ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
NKB
Device Class
Class II
Regulation
21 CFR Part 888.3070
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

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

The DALI Spinal Fixation System is an orthopedic device designed to provide spinal immobilization and stabilization as an adjunct to fusion. It includes titanium alloy or CoCrMo alloy screws, set screws, rods, crosslinks, and connectors for posterior pedicle (T1-S2/ilium) or anterolateral (T8-L5) fixation.

The device is supplied as a sterile, single-use system and is cleared under FDA 510(k) authorization (K121568) through the Traditional pathway. It is intended for use in clinical settings by surgeons and requires proper storage conditions as specified by the manufacturer.

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Questions

AI-generated answers, 1 Oct 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 DALI Spinal Fixation System used for?

    The DALI Spinal Fixation System is an orthopedic device designed to provide spinal immobilization and stabilization as an adjunct to fusion. It is intended for use in clinical settings by surgeons.

  • What materials are used in the DALI Spinal Fixation System?

    The system includes screws, set screws, rods, crosslinks, and connectors made from either titanium alloy or CoCrMo alloy.

  • Is the DALI Spinal Fixation System sterile and single-use?

    Yes, the device is supplied as a sterile, single-use system intended for use in clinical settings by surgeons.

  • What fixation approaches does the DALI Spinal Fixation System support?

    The system is designed for posterior pedicle fixation (T1-S2/ilium) or anterolateral fixation (T8-L5).

  • What are the storage requirements for the DALI Spinal Fixation System?

    The device requires proper storage conditions as specified by the manufacturer to maintain its sterility and functionality.