510(k) K251431

FIX-C PEEK ACIF SA System by Jeil Medical Corporation — Product Code OVE

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: June 27, 2025
Date Received: May 8, 2025
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 Jeil Medical Corporation

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K242247 — ARIX Femur Nail System (April 22, 2025)
K243915 — FIX-C 3D Ti ACIF System (February 18, 2025)
K243004 — Xpine Spinal Fixation System (November 8, 2024)
K231251 — FlexWing Anterior Cervical Plate System (July 24, 2024)
K233912 — ARIX Cannulated Screw System (March 11, 2024)
K231887 — ARIX Ankle Distal Tibia System (December 14, 2023)
K231441 — ARIX Ankle System (July 17, 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)
K251117 — Cervical Spine Truss System (CSTS) (April 25, 2025)
K242928 — Tesera-k SC System (April 10, 2025)
K243188 — CYLOX® ST (February 11, 2025)
K242483 — Genesys Spine AIS-C II Cervical Interbody Fusion System (February 7, 2025)