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IB3D™ PL Spinal System

by Medicrea International S.A.S. (Medtronic)

510(k) K241164

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK241164 Date6 Sep 2024ClearedStatusActive

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  • Withdrawn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 — 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

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