510(k) K212562

Idys-C ZP 3DTi by Clariance, SA — Product Code OVE

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: October 12, 2021
Date Received: August 13, 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 Clariance, SA

K243904 — Elegance® Anterior Cervical plate (January 14, 2025)
K243670 — Idys® LIF (December 31, 2024)
K241863 — Erisma® Lp Spinal Fixation System; Erisma® LP MIS (July 24, 2024)
K240872 — Erisma® Deformity Spinal System; Erisma® Lp Spinal Fixation System (April 26, 2024)
K240715 — Idys® C ZP 3DTi (March 22, 2024)
K220182 — Aggeris-C (March 30, 2022)
K200919 — Idys ALIF 3DTi (April 12, 2021)
K202032 — Idys LLIF 3DTi (April 1, 2021)
K202956 — Erisma LP Navigated Instruments (February 26, 2021)
K200920 — Idys ALIF ZP 3DTi (May 29, 2020)

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)