Home / 510(k) Clearances / K231090

510(k) K231090

Zevo Anterior Cervical Plate System by Medtronic Sofamor Danek USA, Inc. — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 15, 2023
Date Received
April 17, 2023
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Appliance, Fixation, Spinal Intervertebral Body
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type

Other clearances by Medtronic Sofamor Danek USA, Inc.

  • K254165 — Infinity™ OCT System (January 21, 2026)
  • K253941 — CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly) (January 7, 2026)
  • K253335 — CD Horizon™ Spinal System (October 24, 2025)
  • K253129 — Infinity™ OCT System (October 24, 2025)
  • K251444 — Endoskeleton™ Interbody Systems (September 4, 2025)
  • K251395 — The Rialto™ SI Fusion System (June 26, 2025)
  • K250669 — Adaptix™ Interbody System with Titan nanoLOCK™ Surface Technology (April 22, 2025)
  • K241992 — Catalyft™ LS Expandable Interbody System (October 28, 2024)
  • K243007 — CD Horizon™ Spinal System (October 23, 2024)
  • K233951 — CD Horizon ModuLeX Spinal System (Shanks, Head Assemblies, and Set Screw) (March 27, 2024)

Other clearances for product code KWQ

  • K260015 — ANTERIS Thoracolumbar Plate System (March 4, 2026)
  • K251940 — PathLoc Lumbar Plate System (March 3, 2026)
  • K254182 — Aster (February 26, 2026)
  • K253201 — Lumbar Spine Truss System - Plating Solution (LSTS-PS) (February 12, 2026)
  • K252611 — aprevo® cervical plating system (December 22, 2025)
  • K251965 — Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) (August 28, 2025)
  • K251436 — Resolve Anterior Cervical Plate System (July 11, 2025)
  • K250446 — Frida™ Anterior Cervical Plate System (May 23, 2025)
  • K250602 — X-PAC® N-GAGE™ Lumbar Plate System (May 20, 2025)
  • K250486 — Skyway Anterior Cervical Plate System (April 10, 2025)