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510(k) K241464

ARx® SAI Implant System by Life Spine, Inc. — Product Code OUR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 29, 2024
Date Received
May 23, 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 Life Spine, Inc.

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  • K232611 — TruLift Micro Expandable Spacer System & TruLift Expandable Spacer System (November 30, 2023)
  • K231704 — Pro-Link® & Pro-Link® Ti Barbs Cervical Spacer System (October 19, 2023)
  • K223430 — ProLift Micro Expandable Spacer System (May 4, 2023)

Other clearances for product code OUR

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  • 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)