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LEUCADIA AUTOLOK Pedicle Screw System

by Clearview Orthopedic Development, LLC

510(k) K182339

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK182339 Date12 Dec 2018ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 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  • Withdrawn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 Leucadia Autolok Pedicle Screw System is a thoracolumbosacral pedicle screw system intended to be used as an adjunct to fusion using autograft or allograft in posterior, non-cervical fixation. It is indicated for conditions including degenerative disc disease, defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies.

The device is supplied non-sterile and requires sterilization prior to use. It is intended for single-use application in surgical settings. The system includes various sizes of pedicle screws and related components as specified in the product code NKB. Authorization is based on FDA 510(k) clearance K182339, determined to be substantially equivalent to a predicate device.

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 Leucadia Autolok Pedicle Screw System used for?

    The Leucadia Autolok Pedicle Screw System is intended as an adjunct to fusion using autograft or allograft in posterior, non-cervical fixation of the thoracolumbosacral spine, specifically for conditions like degenerative disc disease confirmed by history and radiographic studies.

  • How is the Leucadia Autolok Pedicle Screw System supplied and prepared for use?

    The device is supplied non-sterile and requires sterilization by the user prior to surgical use; it is intended for single-use application only in a surgical setting.

  • What sizes and components are included in the Leucadia Autolok Pedicle Screw System?

    The system includes various sizes of pedicle screws and related components as specified in the product code NKB, though exact dimensions are not detailed in the provided data.

  • What regulatory pathway was used for the Leucadia Autolok Pedicle Screw System?

    The Leucadia Autolok Pedicle Screw System received FDA 510(k) clearance under K182339, based on a determination of substantial equivalence to a predicate device.