510(k) K181621

Stable-C Interbody System by Nexus Spine, LLC — Product Code OVE

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 19, 2018
Date Received: June 20, 2018
Clearance Type: Traditional
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 Nexus Spine, LLC

K253331 — PressON Spinal Fixation System (October 14, 2025)
K243934 — Stable-L Lumbar Interbody System (April 30, 2025)
K241467 — Stable-C Interbody System (July 17, 2024)
K233375 — Tranquil-L Interbody System (March 20, 2024)
K240416 — Tranquil-C Interbody System (March 12, 2024)
K233234 — PressON Spinal Fixation System (October 26, 2023)
K231486 — Stable-L Standalone Lumbar Interbody System (October 12, 2023)
K232530 — Stable-L Standalone Lumbar Interbody System, Stable-C Interbody System (September 18, 2023)
K231763 — Stable-C Interbody System (August 21, 2023)
K223529 — PressON Spinal Fixation System (May 2, 2023)

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)