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510(k) K250403

Catamaran SI Joint Fusion System by Tenon Medical — Product Code OUR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2025
Date Received
February 12, 2025
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 Tenon Medical

  • K231944 — CATAMARAN SI Joint Fusion System (August 24, 2023)
  • K180818 — Catamaran Sacroiliac Joint Fixation System (CAT SIJ Fixation System) (June 13, 2018)

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)