510(k) K172484

A-CIFT SoloFuse by Spinefrontier, Inc. — Product Code OVE

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 8, 2018
Date Received: August 17, 2017
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 Spinefrontier, Inc.

K193106 — SpineFrontier Lumbar Interbody Fusion Device System (June 19, 2020)
K151198 — A-CIFT SoloFuse (July 17, 2015)
K142504 — SpineFrontier Lumbar Interbody Fusion Device System (May 13, 2015)
K150017 — SpineFrontier SIJFuse Sacroiliac Joint Fusion Device System (April 24, 2015)
K143377 — PedFuse Pedicle Screw System (February 12, 2015)
K141333 — ARENA-C TIFUSE CERVICAL INTERVERTEBRAL BODY FUSION DEVICE (November 25, 2014)
K142026 — SPINEFRONTIER ARENA-C HA PEEK CERVICAL INTERVERTEBRAL BODY FUSION DEVICE (October 20, 2014)
K141337 — ARENA-C (September 8, 2014)
K133153 — SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM (May 14, 2014)
K131880 — SPINEFRONTIER A-CIFT SOLOFUSE CERVICAL INTERVERTEBRAL FUSION DEVICE SYSTEM (January 3, 2014)

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)