Cleared Special

K220096 - Genesys Spine 3DP Lumbar Interbody System
(FDA 510(k) Clearance)

K220096 · Genesys Spine · Orthopedic

Mar 2022

Decision

56d

Days

Class 2

Risk

K220096 is an FDA 510(k) clearance for the Genesys Spine 3DP Lumbar Interbody System, a Intervertebral Fusion Device With Bone Graft, Lumbar (Class II — Special Controls, product code MAX), submitted by Genesys Spine (Austin, US). The FDA issued a Cleared decision on March 9, 2022, 56 days after receiving the submission on January 12, 2022. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K220096 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 12, 2022
Decision Date	March 09, 2022
Days to Decision	56 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.