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510(k) K162733

iFuse Implant System® - iFuse-3D implant by SI-BONE, Inc. — Product Code OUR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 2017
Date Received
September 29, 2016
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 SI-BONE, Inc.

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  • K241504 — iFuse TORQ TNT™ Implant System (August 19, 2024)
  • K241574 — iFuse TORQ® Implant System (July 2, 2024)
  • K232800 — Navigation Tracking Instruments (February 23, 2024)
  • K233508 — iFuse Bedrock Granite® Implant System (January 26, 2024)
  • K231689 — iFuse TORQ® Implant System (June 30, 2023)
  • K222774 — iFuse Bedrock Granite® Implant System (December 22, 2022)
  • K222605 — iFuse TORQ® Implant System (September 29, 2022)

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)