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Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System

by Zavation Medical Products, LLC

510(k) K233509

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 NumberK233509 Date10 Apr 2024ClearedStatusActive

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  • Withdrawn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, 25 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 device is an intervertebral body fusion (IBF) system, which includes the Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, and Zavation ALIF System. It is an integrated lumbar spacer comprised of a plate, cage, and fixation, and may include the NanoPrime® IBF or F3D-Z cages, as well as anchor and/or screw fixation.

The device is supplied by Zavation Medical Products, LLC and received FDA 510(k) clearance under K233509 on April 10, 2024. It is classified under product code MAX and regulation number 21 CFR 888.3080 for intervertebral body fusion devices. The device is intended for use in orthopedic spinal procedures as indicated by the advisory committee classification.

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Questions

AI-generated answers, 25 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 Zavation IBF System used for?

    The Zavation IBF System is intended for use in orthopedic spinal procedures as an intervertebral body fusion device, indicated by the advisory committee classification for orthopedic applications, to facilitate spinal fusion through integrated lumbar spacer components including plate, cage, and fixation.

  • How is the Zavation IBF System supplied and what does it include?

    The device is supplied by Zavation Medical Products, LLC and includes an integrated lumbar spacer comprised of a plate, cage, and fixation, and may include the NanoPrime® IBF or F3D-Z cages, as well as anchor and/or screw fixation components as part of the system.

  • What regulatory pathway was used for the Zavation IBF System and when was it cleared?

    The device received FDA 510(k) clearance under K233509 on April 10, 2024, following a traditional review process, and was found substantially equivalent to a predicate device under product code MAX and regulation 21 CFR 888.3080.