510(k) K162531

STERISPINE CC by Safe Orthopaedics — Product Code OVE

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 29, 2016
Date Received: September 9, 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 Safe Orthopaedics

K201648 — Sterispine PS (July 30, 2020)
K170528 — Sterispine PS (March 9, 2017)
K151921 — STERISPINE PS (October 8, 2015)
K151747 — STERISPINE PS (October 5, 2015)
K151756 — STERISPINE LC CAGE (August 21, 2015)
K150092 — STERISPINE PS Pedicle Screw (February 10, 2015)
K140802 — STERISPINE PS (June 4, 2014)
K133893 — STERISPINE LC CAGE (March 14, 2014)
K130632 — STERISPINE PS PEDICLE SCREW (May 3, 2013)
K122021 — STERISPINE LC CAGE (September 20, 2012)

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)