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510(k) K193000

Hexanium® ACIF by Spinevision, S.A.S. — Product Code OVE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 2020
Date Received
October 28, 2019
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 Spinevision, S.A.S.

  • K223251 — Hexanium PLIF (December 16, 2022)
  • K221578 — Hexanium ACIF (November 14, 2022)
  • K210359 — Hexanium TLIF (March 10, 2021)
  • K180437 — Hexanium® TLIF (May 4, 2018)
  • K153783 — SpaceVision® PLIF, SpaceVision® OLIF, SpaceVision® TLIF (May 4, 2016)
  • K160124 — LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation (April 4, 2016)
  • K133575 — SPINEVISION LUMIS CANNULATED PEDICLE SCREW FIXATION SYSTEM, SPINEVISION U.L.I.S. (June 30, 2014)
  • K130302 — SPINEVISION LUMIS CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEVISIO (July 30, 2013)
  • K112607 — SPINEVISION LUMIS(TM) CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM, SPINEV (June 7, 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)