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510(k) K241813

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 2024
Date Received
June 21, 2024
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-Technology, LLC

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  • 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)