Home / 510(k) Clearances / K191778

510(k) K191778

Omnia Medical VBR by Omnia Medical, LLC — Product Code PLR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 2019
Date Received
July 2, 2019
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spinal Vertebral Body Replacement Device - Cervical
Device Class
Class II
Regulation Number
888.3060
Review Panel
OR
Submission Type

Vertebral body replacement in the cervical spine.

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)
  • K192096 — Omnia Medical Trauma Screws (February 27, 2020)
  • K190363 — Omnia Medical TiBrid Cervical Cage, Omnia Medical TiBrid Lateral Cage, Omnia Med (February 21, 2020)
  • K183659 — Omnia Medical Rotary PLIF System (February 6, 2019)
  • K172323 — Omnia Medical VBR (October 26, 2017)

Other clearances for product code PLR

  • K252560 — Atlas Spine HiRISE™ Expandable Cervical Corpectomy System (November 10, 2025)
  • K232481 — RIGEL™ 3DR Anterior Cervical Corpectomy System (October 13, 2023)
  • K221542 — Galileo Vertebral Body Replacement Device (January 13, 2023)
  • K212126 — MediExpand Cervical Expandable VBR System (April 4, 2022)
  • K211320 — CAPRI Corpectomy Cage System (February 24, 2022)
  • K192145 — Galileo Vertebral Body Replacement Device (April 21, 2020)
  • K193412 — NEXXT MATRIXX System (February 24, 2020)
  • K190284 — Bengal Stackable Cage System (December 20, 2019)
  • K190426 — ALTA Anterior Cervical Corpectomy System (October 24, 2019)
  • K191423 — Normandy VBR System (August 6, 2019)