Home / 510(k) Clearances / K223321

510(k) K223321

Omnia Medical Coupler-C Anterior Cervical Plate by Omnia Medical, LLC — Product Code KWQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 2023
Date Received
October 31, 2022
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 Omnia Medical, LLC

  • K242431 — Omnia Medical PsiF DNA™ System (June 6, 2025)
  • K240623 — Omnia Medical TiBrid™-SA System (April 24, 2024)
  • K230424 — Omnia Medical Coupler-A™ Anterior Lumbar Plate System; Omnia Medical Coupler-L™ (April 12, 2023)
  • K212612 — Omnia Medical TiBrid-SC (November 15, 2022)
  • K203207 — Omnia Medical TiBrid-SA (December 23, 2020)
  • K192096 — Omnia Medical Trauma Screws (February 27, 2020)
  • K190363 — Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia Med (February 21, 2020)
  • K191778 — Omnia Medical VBR (August 28, 2019)
  • K183659 — Omnia Medical Rotary PLIF System (February 6, 2019)
  • K172323 — Omnia Medical VBR (October 26, 2017)

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)