Home / 510(k) Clearances / K242431

510(k) K242431

Omnia Medical PsiF DNA™ System by Omnia Medical, LLC — Product Code OUR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2025
Date Received
August 16, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sacroiliac Joint Fixation
Device Class
Class II
Regulation Number
888.3040
Review Panel
OR
Submission Type

sacroiliac joint fusion

Other clearances by Omnia Medical, LLC

  • 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)
  • 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 OUR

  • K253488 — iFuse INTRA Ti™ Implant System (February 11, 2026)
  • K253611 — Falco Fusion System (January 29, 2026)
  • K252834 — Sacroiliac Joint Truss System (SJTS) (January 28, 2026)
  • K251365 — OptumSI Implant System (November 20, 2025)
  • K252322 — SIros-X System (October 22, 2025)
  • K253094 — iFuse Bedrock Granite Implant System (October 9, 2025)
  • K250894 — Eminent Spine Posterior SI System (October 7, 2025)
  • K250647 — SImmetry+ System (July 29, 2025)
  • K250247 — panaSIa SI Fusion System (July 9, 2025)
  • K251395 — The Rialto™ SI Fusion System (June 26, 2025)