Cleared Special

restor3d TIDAL Lumbar Interbody Fusion System

K234087 · Restor3d · Orthopedic

Jan 2024

Decision

31d

Days

Class 2

Risk

About This 510(k) Submission

K234087 is an FDA 510(k) clearance for the restor3d TIDAL Lumbar Interbody Fusion System, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by Restor3d (Durham, US). The FDA issued a Cleared decision on January 22, 2024, 31 days after receiving the submission on December 22, 2023. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K234087 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 22, 2023
Decision Date	January 22, 2024
Days to Decision	31 days
Submission Type	Special
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.