Cleared Traditional

Genesys Spine AIS-C II Cervical Interbody Fusion System

K242483 · Genesys Spine · Orthopedic

Feb 2025

Decision

170d

Days

Class 2

Risk

About This 510(k) Submission

K242483 is an FDA 510(k) clearance for the Genesys Spine AIS-C II Cervical Interbody Fusion System, a Intervertebral Fusion Device With Integrated Fixation, Cervical (Class II — Special Controls, product code OVE), submitted by Genesys Spine (Austin, US). The FDA issued a Cleared decision on February 7, 2025, 170 days after receiving the submission on August 21, 2024. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3080.

Submission Details

510(k) Number	K242483 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 21, 2024
Decision Date	February 07, 2025
Days to Decision	170 days
Submission Type	Traditional
Review Panel	Orthopedic (OR)
Summary	Summary PDF

Device Classification

Product Code	OVE — Intervertebral Fusion Device With Integrated Fixation, Cervical
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 888.3080
Definition	Intended To Stabilize Cervical Spinal Segment To Promote Fusion In Order To Restrict Motion And Decrease Pain Using Bone Graft With Or Without Supplemental Fixation.