Cleared Special

K233594 - Genesys Spine 3DP AIS-C II Cervical Interbody System
(FDA 510(k) Clearance)

K233594 · Genesys Spine · Orthopedic
Dec 2023
Decision
35d
Days
Class 2
Risk

K233594 is an FDA 510(k) clearance for the Genesys Spine 3DP AIS-C II Cervical Interbody System. This device is classified as 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 December 13, 2023, 35 days after receiving the submission on November 8, 2023.

This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3080. 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..

Submission Details

510(k) Number K233594 FDA.gov
FDA Decision Cleared SESE
Date Received November 08, 2023
Decision Date December 13, 2023
Days to Decision 35 days
Submission Type Special
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.

Similar Devices — OVE Intervertebral Fusion Device With Integrated Fixation, Cervical

All 156
E3D?-C Interbody System
K260038 · Evolution Spine · Feb 2026
HEDRON? Cervical Spacers (HEDRON C-MIS? Spacer)
K253876 · Globus Medical, Inc. · Dec 2025
Cervical Spine Truss System - Stand Alone (CSTS-SA)
K253200 · 4Web Medical, Inc. · Dec 2025
Endeavor? Stand-Alone Cervical IBF System
K250076 · Innovasis · Sep 2025
SABER-C System
K250540 · Elevation Spine · Aug 2025
Stabilis SA Cervical Stand-Alone System (Various PNs)
K251735 · Acuity Surgical Devices, LLC · Jul 2025