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510(k) K232149

BowTie™ SI Joint Fusion System by Sail Fusion, LLC — Product Code OUR

K232149 is an FDA 510(k) premarket notification submitted by Sail Fusion, LLC for the device "BowTie™ SI Joint Fusion System". The FDA issued a decision of Substantially Equivalent on April 20, 2024. The device falls under product code OUR (Sacroiliac Joint Fixation), a Class II device regulated under 21 CFR 888.3040.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 2024
Date Received
July 19, 2023
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 for product code OUR

  • K260477 — CATAMARAN™ SI Joint Fusion System (April 8, 2026)
  • 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)

FDA data resources