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510(k) K251525

SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System by Si-Technology, LLC — Product Code OUR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2025
Date Received
May 19, 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 Si-Technology, LLC

  • K241813 — SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion System (August 13, 2024)
  • K151462 — SI-TECHNOLOGY® SI-DESIS® SCREWS (August 12, 2015)

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  • K250647 — SImmetry+ System (July 29, 2025)
  • K250247 — panaSIa SI Fusion System (July 9, 2025)
  • K251395 — The Rialto™ SI Fusion System (June 26, 2025)