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IB3D PL Spinal System (A24000000 / IB3D Universal Implant Inserter)

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

510(k) K253577

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

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 · Special NumberK253577 Date19 Dec 2025ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 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  • Withdrawn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, 19 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 IB3D PL Spinal System is an Intervertebral Fusion Device With Bone Graft, Lumbar, designed for spinal surgical applications. It includes the IB3D Universal Implant Inserter, a tool used to facilitate the precise placement of interbody fusion implants in the lumbar spine, promoting spinal stability and fusion.

This system is intended for use in orthopedic surgical settings and is supplied as a reusable medical device. The IB3D Universal Implant Inserter is classified under FDA product code MAX and holds a 510(k) clearance with a Substantially Equivalent (SESE) determination. It is manufactured by Medicrea International S.A.S. (Medtronic) and adheres to regulatory standards for spinal orthopedic devices.

Other devices from Medicrea International S.A.S. (Medtronic)