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Idys ALIF 3DTi

by Clariance

510(k) K200919

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 NumberK200919 Date12 Apr 2021ClearedStatusActive

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  • Withdrawn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
MAX
Device class
Class II
Regulation
21 CFR Part 888.3080
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 Idys ALIF 3DTi is a class III medical device designed for anterior lumbar interbody fusion (ALIF) procedures. It is manufactured by Clariance SAS in France and is intended for use in spinal stabilization and fusion surgeries.

The device is supplied in sterile packaging and is available in multiple footprint sizes, heights, and lordotic angles. It has received FDA 510(k) clearance under K200919 with product code MAX and is classified as substantially equivalent to a predicate device. The device is intended for single-use and must be used in accordance with the manufacturer's instructions for use and surgical technique.

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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 Idys ALIF 3DTi used for?

    The Idys ALIF 3DTi is designed for anterior lumbar interbody fusion (ALIF) procedures to achieve spinal stabilization and fusion in the lumbar spine, as intended by the manufacturer for surgical use in stabilization and fusion surgeries.

  • How is the Idys ALIF 3DTi supplied and is it reusable?

    The device is supplied in sterile packaging and is intended for single-use only; it must not be reused and should be used in accordance with the manufacturer's instructions for use and surgical technique to ensure patient safety and device performance.

  • What sizes and configurations are available for the Idys ALIF 3DTi?

    The Idys ALIF 3DTi is available in multiple footprint sizes, heights, and lordotic angles to accommodate varying patient anatomies and surgical needs during anterior lumbar interbody fusion procedures.

  • What regulatory clearance does the Idys ALIF 3DTi have?

    The Idys ALIF 3DTi has received FDA 510(k) clearance under submission number K200919 with product code MAX and is classified as substantially equivalent to a predicate device, as indicated in the device's authorization data.