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FDA 510(k)

panaSIa SI Fusion System

K-Number: K250247 · 2025-07-09

ApplicantWenzel Spine, Inc.
Decision Date2025-07-09
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

panaSIa SI Fusion System is a medical device manufactured by Wenzel Spine, Inc.. It received FDA 510(k) clearance on 2025-07-09 under approval number K250247. The device is classified under product code OUR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the panaSIa SI Fusion System?

panaSIa SI Fusion System is a medical device that received FDA 510(k) clearance on 2025-07-09. It is manufactured by Wenzel Spine, Inc.. The 510(k) number is K250247.

When was panaSIa SI Fusion System approved by the FDA?

panaSIa SI Fusion System received FDA 510(k) clearance on 2025-07-09, under approval number K250247.

What company makes panaSIa SI Fusion System?

panaSIa SI Fusion System is manufactured by Wenzel Spine, Inc..

What is the FDA product code for panaSIa SI Fusion System?

The FDA product code for panaSIa SI Fusion System is OUR.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT04305925 Focal Laser Ablation of Prostate Cancer COMPLETED NCT07023393 Proprio Spine Measurement Tool WITHDRAWN NCT07485829 Zimmer Biomet-RibFix Titan RECRUITING NCT02759744 Fusion Guided Focal Laser Ablation of Prostate Cancer ENROLLING_BY_INVITATION

Other Devices by Wenzel Spine, Inc.

K180822VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System K231076VariLift®-C Interbody Fusion System K231807primaLOK™ SP Interspinous Fusion System

Related Devices (Code: OUR)

K161755Integrity-SI TM Fusion SystemCoorstek Medical K153656PathLoc-SI Joint Fusion SystemL&K BIOMED Co., Ltd. K161210RIALTO(TM) SI Fusion System, Medtronic Reusable Instruments for Use with the IPC(TM) Powerease(TM) System, and Medtronic Navigated Manual Reusable Instruments for use with the StealthStation(TM) and IPC(TM) Powerease(TM) SystemsMedtronic Sofamor Danek K160652iFUSE Implant SystemSI-BONE, Inc. K152681iFuse Implant System(R)SI-BONE, Inc. K152237The Entasis Dual-Lead Sacroiliac ImplantCorelink, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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