Cleared Traditional

restor3d TiDAL Lumbar Interbody Fusion Device

K220523 · Restor3d · Orthopedic

Jun 2022

Decision

114d

Days

Class 2

Risk

About This 510(k) Submission

K220523 is an FDA 510(k) clearance for the restor3d TiDAL Lumbar Interbody Fusion Device, 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 June 17, 2022, 114 days after receiving the submission on February 23, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K220523 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 23, 2022
Decision Date	June 17, 2022
Days to Decision	114 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.