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Spinal Fixation System

by Lanx, Inc.

510(k) K092536

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 NumberK092536 Date30 Oct 2009ClearedStatusActive

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  • Withdrawn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 Spinal Fixation System is a surgical orthopedic device classified as a spinal fixation implant. It is designed to provide posterior, non-cervical stabilization of the thoracic (T1–S2), lumbar, and sacral spine, including the ilium, through pedicle and non-pedicle fixation. This system is intended for immobilization and spinal segmental stabilization as an adjunct to spinal fusion in skeletally mature patients.

The device is supplied as a reusable surgical implant and is regulated under FDA 510(k) clearance (K092536) as substantially equivalent to a predicate device. It is intended for use in orthopedic settings and is not indicated for MRI compatibility. Sizes and configurations are determined by anatomical requirements and surgical planning, with no specified sterility or single-use designation in the provided data.

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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 Spinal Fixation System designed for?

    The Spinal Fixation System is intended for posterior, non-cervical stabilization of the thoracic (T1–S2), lumbar, and sacral spine, including the ilium. It provides immobilization and segmental stabilization as an adjunct to spinal fusion in skeletally mature patients, ensuring structural support during the healing process.

  • Is the Spinal Fixation System single-use or reusable?

    The Spinal Fixation System is designed as a reusable surgical implant. This classification allows for multiple uses within a clinical setting, provided proper cleaning, sterilization, and maintenance protocols are followed between procedures.

  • What anatomical regions does this system cover?

    This system is specifically designed for the thoracic spine (T1–S2), lumbar spine, sacral spine, and the ilium. The fixation can be achieved through both pedicle and non-pedicle approaches, depending on the surgical plan and anatomical requirements.

  • How are sizes and configurations determined for this device?

    Sizes and configurations of the Spinal Fixation System are tailored to the patient’s anatomical requirements and are determined during surgical planning. The system is adaptable to accommodate individual patient needs, ensuring proper alignment and stabilization.

  • Is the Spinal Fixation System compatible with MRI?

    No, the Spinal Fixation System is explicitly not indicated for MRI compatibility. This means it should not be used in patients who require MRI imaging post-surgery, as the device may interfere with imaging results or pose safety risks.