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Giza(R) Vertebral Body Replacement

by Eden Spine, LLC

510(k) K112429

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK112429 Date26 Jan 2012ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-2072-2017 FDA Class II initiated 17 Mar 2017

    Complaints that implants have been disassembled by surgeons because of unscrewing completely the locking screw.

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  • Withdrawn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

Other devices from Eden Spine, LLC

  • Sphynx

    Class II