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IB3D™ PL Spinal System B241C07062209

by Medicrea International SA

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

2 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03613720288008 UDI-DI Date7 Sep 2026ListedStatusListed GUDID: in commercial distribution

Recalls

2 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-1038-2026 FDA Class II initiated 29 Oct 2025
    • Ongoing Z-1039-2026 FDA Class II initiated 29 Oct 2025

    Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
IB3D™ PL Spinal System
Generic Name
Metallic spinal interbody fusion cage
Model / Reference
B241C07062209
Primary DI / UDI-DI
03613720288008
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
MRI Safety
MR Conditional

Related devices

Cleared under the same submission (K241164)

Show all (12)

Other devices from Medicrea International SA

See all devices from Medicrea International SA →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number

Other properties (9)

  • 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