Home / 510(k) Clearances / K192096

510(k) K192096

Omnia Medical Trauma Screws by Omnia Medical, LLC — Product Code HWC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 2020
Date Received
August 5, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Screw, Fixation, Bone
Device Class
Class II
Regulation Number
888.3040
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)
  • K223321 — Omnia Medical Coupler-C Anterior Cervical Plate (March 13, 2023)
  • K212612 — Omnia Medical TiBrid-SC (November 15, 2022)
  • K203207 — Omnia Medical TiBrid-SA (December 23, 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 HWC

  • K260361 — Treace Medical Concepts (TMC) Screw Fixation System (March 6, 2026)
  • K252901 — Tyber Medical Trauma Screw (December 31, 2025)
  • K251555 — Ultra™ Compression Screw System (November 6, 2025)
  • K252312 — Eleganz IM Threaded Nail System (IM Threaded Nail System) (October 10, 2025)
  • K250536 — MetaFore Small Screw System (October 8, 2025)
  • K252758 — Cannulated Screw and Kirschner (K wire) System (October 2, 2025)
  • K252019 — CurvaFix Low Profile System (August 29, 2025)
  • K251382 — Phoenix Sinus Tarsi Stent System (August 27, 2025)
  • K250867 — Dunamis Screw and Suture Locking System (August 15, 2025)
  • K250251 — Eleganz Fusion Screw System (Fusion Screw System) (June 13, 2025)