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510(k) K203373

Advanced Research Medical Trident SI Screw System by Advanced Research Medical, LLC — Product Code OUR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 22, 2021
Date Received
November 16, 2020
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 Advanced Research Medical, LLC

  • K173947 — Lumbar Interbody Fusion System (OLLIF) (July 25, 2018)

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