Cleared Traditional

IB3D? PL Spinal System

K241164 · Medicrea International S.A.S. (Medtronic) · Orthopedic

Sep 2024

Decision

133d

Days

Class 2

Risk

About This 510(k) Submission

K241164 is an FDA 510(k) clearance for the IB3D? PL Spinal System, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by Medicrea International S.A.S. (Medtronic) (Rillieux-La-Pape, FR). The FDA issued a Cleared decision on September 6, 2024, 133 days after receiving the submission on April 26, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K241164 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 26, 2024
Decision Date	September 06, 2024
Days to Decision	133 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	MAX — Intervertebral Fusion Device With Bone Graft, Lumbar
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3080
Definition	Intended To Stabilize Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft.