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510(k) K240720

TiLink-P SI Joint Fusion System by SurGenTec, LLC — Product Code OUR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 11, 2024
Date Received
March 15, 2024
Clearance Type
Special
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 SurGenTec, LLC

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  • K251720 — OsteoFlo HydroFiber (July 2, 2025)
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  • K243945 — ALARA BMA Neuro Access Kit (ALARA BMAN and ALARA BMAC Kit) (April 24, 2025)
  • K243580 — GraftGun Universal Graft Delivery System (GDS) (February 5, 2025)
  • K243835 — TiLink-P SI Joint Fusion System (December 27, 2024)
  • K242797 — OsteoFlo HydroFiber (December 23, 2024)
  • K243265 — Ion 3D (December 4, 2024)
  • K242414 — TiLink-P Joint Fusion System (November 21, 2024)
  • K242141 — TiLink-P SI Joint Fusion System (August 21, 2024)

Other clearances for product code OUR

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  • 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)