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510(k) K220274

Kisar Stratford SI Screw System by Anjali Investments L.L.C — Product Code OUR

K220274 is an FDA 510(k) premarket notification submitted by Anjali Investments L.L.C for the device "Kisar Stratford SI Screw System". The FDA issued a decision of Substantially Equivalent on Apr 24, 2023. The device falls under product code OUR (Sacroiliac Joint Fixation), a Class II device regulated under 21 CFR 888.3040.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Apr 24, 2023
Date Received
Jan 31, 2022
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
510(k)

sacroiliac joint fusion

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  • K252322 — SIros-X System (Oct 22, 2025)
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  • K250894 — Eminent Spine Posterior SI System (Oct 7, 2025)
  • K250647 — SImmetry+ System (Jul 29, 2025)

FDA data resources