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Zavation eZspand Interbody System

by Zavation Medical Products, LLC 2 variants

510(k) K220581

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 NumberK220581 Date2 Jun 2022ClearedStatusActive

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  • Withdrawn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, 21 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 eZspand Interbody System is an expandable titanium interbody device designed for spinal fusion procedures. It is intended for use with autogenous bone graft to restore disc height and promote fusion in the lumbar spine.

The system is supplied sterile and is intended for single-use in surgical settings. It is MRI compatible and requires proper storage conditions to maintain sterility. The device has received FDA 510(k) clearance as substantially equivalent to predicate devices.

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