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510(k) K250247

panaSIa SI Fusion System by Wenzel Spine, Inc. — Product Code OUR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 2025
Date Received
January 27, 2025
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 Wenzel Spine, Inc.

  • K231076 — VariLift®-C Interbody Fusion System (September 27, 2023)
  • K231807 — primaLOK™ SP Interspinous Fusion System (August 15, 2023)
  • K180822 — VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System (January 28, 2019)
  • K151900 — VariLift-L Interbody Fusion Device (December 11, 2015)
  • K131296 — VARILIFT-L INTERBODY FUSION DEVICE (September 3, 2013)
  • K120603 — VARILIFT -C (January 29, 2013)
  • K111123 — VARILIFT CERVICAL INTERBODY FUSION SYSTEM (December 8, 2011)
  • K100820 — WENZEL SPINE VARILIFT INTERBODY FUSION SYSTEM (August 5, 2010)

Other clearances for product code OUR

  • K253488 — iFuse INTRA Ti™ Implant System (February 11, 2026)
  • K253611 — Falco Fusion System (January 29, 2026)
  • K252834 — Sacroiliac Joint Truss System (SJTS) (January 28, 2026)
  • 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)
  • K251395 — The Rialto™ SI Fusion System (June 26, 2025)
  • K242431 — Omnia Medical PsiF DNA™ System (June 6, 2025)