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Z-Span Plate System

by Zavation Medical Products, LLC

510(k) K202624

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 NumberK202624 Date4 Nov 2020ClearedStatusActive

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  • Withdrawn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
KWQ
Device Class
Class II
Regulation
21 CFR Part 888.3060
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 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 Z-Span Plate System is a spinal plating system designed to provide lateral spinal stabilization and immobilization as an adjunct to fusion. It is a titanium plate system used in anterior lumbar interbody fusions, featuring low-profile plates including 2-hole and expandable options for supplemental fixation in spinal fusion procedures.

The system is intended for use via the lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of the lumbar spine (L1-L5) or via the anterior approach below the bifurcation of the great vessels in the treatment of the lumbar and lumbosacral spine (L1-S1). It is supplied as a non-sterile, reusable device and has received FDA 510(k) clearance under product code KWQ with K-number K202624.

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Questions

AI-generated answers, 6 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 Z-Span Plate System used for?

    The Z-Span Plate System is designed to provide lateral spinal stabilization and immobilization as an adjunct to fusion in anterior lumbar interbody fusions, used via lateral or anterolateral approaches above the great vessel bifurcation for L1-L5 or anterior approach below bifurcation for L1-S1.

  • How is the Z-Span Plate System supplied and is it reusable?

    The Z-Span Plate System is supplied as a non-sterile, reusable device, intended for multiple uses after appropriate cleaning and sterilization by the healthcare facility prior to each surgical procedure.

  • What regulatory pathway was used for the Z-Span Plate System?

    The Z-Span Plate System received FDA 510(k) clearance under product code KWQ with K-number K202624, determined to be substantially equivalent to a predicate device through a traditional review process.