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Forza 89-5006SP

by Orthofix US LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

3 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number18257200026036 UDI-DI Date19 Mar 2019ListedStatusListed GUDID: in commercial distribution

Recalls

3 recalls · 3 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-0893-2026 FDA Class III initiated 3 Nov 2025 on shared 510(k) K172437
    • Ongoing Z-0891-2026 FDA Class III initiated 3 Nov 2025 on shared 510(k) K172437
    • Ongoing Z-0892-2026 FDA Class III initiated 3 Nov 2025

    Labeling contains claims that are not consistently present.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Forza
Generic Name
Metallic spinal interbody fusion cage
Model / Reference
89-5006SP
Primary DI / UDI-DI
18257200026036
510(k) Number
FDA Product Code
MAX
GMDN Term
Metallic spinal interbody fusion cage
Device Class
Class II
Regulation Number
888.3080
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Metallic spinal interbody fusion cage

Cleared under the same submission (K172437)

Show all (12)

Other devices from Orthofix US LLC

See all devices from Orthofix US LLC →

Properties

  • Implantable
  • Prescription Use
  • Lot / Batch Number

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No