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Zavation Buttress Plate System

by Zavation Medical Products, LLC

510(k) K180537

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 NumberK180537 Date27 Mar 2018ClearedStatusActive

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  • Withdrawn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, 24 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 Zavation Buttress Plate System is a spinal intervertebral body fixation orthosis. It is designed to provide stabilization and fixation for the spinal column.

This device is regulated as a Class II medical device under 21 CFR 888.3060 and received FDA 510(k) clearance under K180537. It is manufactured by Zavation Medical Products, LLC.

Other devices from Zavation Medical Products, LLC

See all devices from Zavation Medical Products, LLC →

Questions

AI-generated answers, 24 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 primary purpose of the Zavation Buttress Plate System?

    The Zavation Buttress Plate System is a spinal intervertebral body fixation orthosis. It is specifically designed to provide necessary stabilization and fixation for the spinal column during clinical procedures.

  • How is this device classified for regulatory purposes?

    This device is regulated as a Class II medical device under 21 CFR 888.3060. It received FDA 510(k) clearance under K180537, confirming it is substantially equivalent to existing predicate devices.

  • Who is the manufacturer of the Buttress Plate System?

    The system is manufactured by Zavation Medical Products, LLC, located in Flowood, Mississippi. They are the applicant of record for the FDA 510(k) clearance associated with this spinal orthosis.