510(k) K260038

E3D-C Interbody System by Evolution Spine — Product Code OVE

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: February 4, 2026
Date Received: January 6, 2026
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 Evolution Spine

K250167 — Evolution Spine Navigation Instruments (August 18, 2025)
K241846 — E3D-C Interbody System (August 12, 2024)
K240368 — E3D-A Interbody System (May 15, 2024)
K232432 — E3D-A Interbody System (January 30, 2024)
K223146 — EVOLUTION SPINE Interbody System (February 7, 2023)
K220275 — EMERGE Anterior Cervical Plate System (March 18, 2022)
K212405 — EMERGE Anterior Cervical Plate System (September 30, 2021)
K182478 — Whistler Modular Pedicle Screw System (January 15, 2019)
K180755 — Vail ALIF Buttress Plate System (July 6, 2018)
K173375 — Anterior Cervical Plate System (December 21, 2017)

Other clearances for product code OVE

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)
K242483 — Genesys Spine AIS-C II Cervical Interbody Fusion System (February 7, 2025)