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510(k) K250001

Patriot SI Implant System by Spinal Simplicity, LLC — Product Code OUR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 2025
Date Received
January 2, 2025
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 Spinal Simplicity, LLC

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  • K233527 — Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterio (November 29, 2023)
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  • K221023 — Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA (August 19, 2022)
  • K211880 — Minuteman G5 MIS Fusion Plate (March 11, 2022)
  • K212781 — Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, (December 15, 2021)

Other clearances for product code OUR

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  • 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)