510(k) K210573

Velofix SA Cervical Cage by U&I Corporation — Product Code OVE

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 19, 2021
Date Received: February 26, 2021
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 U&I Corporation

K220147 — Aspiron S ACP System (February 16, 2022)
K183243 — Velofix TLIF Cage (July 10, 2019)
K190067 — Velofix Interbody Fusion System (February 4, 2019)
K190053 — SECULOK ACP System (February 1, 2019)
K181824 — CBT Screw Fixation System (December 13, 2018)
K183383 — ANAX OCT Spinal System (December 12, 2018)
K181829 — Velofix TLIF Cage (November 14, 2018)
K182055 — SECULOK ACP System (September 10, 2018)
K180759 — SECULOK Suture Anchor (August 9, 2018)
K173198 — Facet Screw Fixation System (January 3, 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)