510(k) K163474

CAVUX CervicalCage-L SA System by Providence Medical Technology, Inc. — Product Code OVE

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: March 10, 2017
Date Received: December 12, 2016
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 Providence Medical Technology, Inc.

K253190 — CORUS-LX Implant (November 20, 2025)
K251060 — CORUS Navigation System-GX (July 30, 2025)
K251885 — CAVUX Facet Fixation System (CAVUX FFS) and CORUS-LX Implant (July 10, 2025)
K241035 — PMT Posterior Cervical Stabilization System (PCSS) (June 25, 2024)
K240625 — CORUS Navigation Access System (May 3, 2024)
K230840 — PMT Facet Fixation System, Lumbar (PMT FFS-LX) (December 19, 2023)
K230297 — PMT Expandable Cage (PMT EXP) (August 11, 2023)
K220951 — PMT Facet Fixation System (PMT FFS) (December 9, 2022)
K212636 — CORUS Spinal System-X (October 15, 2021)
K183589 — PMT Facet Screw (October 11, 2019)

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)