510(k) K233594

Genesys Spine 3DP AIS-C II Cervical Interbody System by Genesys Spine — Product Code OVE

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 13, 2023
Date Received: November 8, 2023
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Intervertebral Fusion Device With Integrated Fixation, Cervical
Device Class: Class II
Regulation Number: 888.3080
Review Panel: OR
Submission Type

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.

Other clearances by Genesys Spine

K252322 — SIros-X System (October 22, 2025)
K242483 — Genesys Spine AIS-C II Cervical Interbody Fusion System (February 7, 2025)
K233595 — Genesys Spine Sacroiliac Joint Fusion System with Navigation (March 29, 2024)
K220096 — Genesys Spine 3DP Lumbar Interbody System (March 9, 2022)
K191489 — Genesys Spine 3DP Cervical Interbody System (January 8, 2020)
K182987 — Genesys Spine 3DP Lumbar Interbody System (December 12, 2019)
K192678 — Genesys Spine Binary® Lumbar Plate System (October 24, 2019)
K191748 — Genesys Spine Sacroiliac Joint Fusion System (September 26, 2019)
K192076 — Binary® Anterior Cervical Plate System (August 29, 2019)
K181295 — Genesys Spine AIS-C Cervical Stand-Alone System (August 29, 2018)

Other clearances for product code OVE

K260038 — E3D-C Interbody System (February 4, 2026)
K253876 — HEDRON Cervical Spacers (HEDRON C-MIS Spacer) (December 22, 2025)
K253200 — Cervical Spine Truss System - Stand Alone (CSTS-SA) (December 11, 2025)
K250076 — Endeavor Stand-Alone Cervical IBF System (September 25, 2025)
K250540 — SABER-C System (August 8, 2025)
K251735 — Stabilis SA Cervical Stand-Alone System (Various PNs) (July 30, 2025)
K251431 — FIX-C PEEK ACIF SA System (June 27, 2025)
K251117 — Cervical Spine Truss System (CSTS) (April 25, 2025)
K242928 — Tesera-k SC System (April 10, 2025)
K243188 — CYLOX® ST (February 11, 2025)