Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Falco Fusion System

K-Number: K253611 · 2026-01-29

ApplicantMcnicoll Surgical, Inc.
Decision Date2026-01-29
Product CodeOUR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Falco Fusion System is a medical device manufactured by Mcnicoll Surgical, Inc.. It received FDA 510(k) clearance on 2026-01-29 under approval number K253611. 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 Falco Fusion System?

Falco Fusion System is a medical device that received FDA 510(k) clearance on 2026-01-29. It is manufactured by Mcnicoll Surgical, Inc.. The 510(k) number is K253611.

When was Falco Fusion System approved by the FDA?

Falco Fusion System received FDA 510(k) clearance on 2026-01-29, under approval number K253611.

What company makes Falco Fusion System?

Falco Fusion System is manufactured by Mcnicoll Surgical, Inc..

What is the FDA product code for Falco Fusion System?

The FDA product code for Falco 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NCT04305925 Focal Laser Ablation of Prostate Cancer COMPLETED NCT07023393 Proprio Spine Measurement Tool WITHDRAWN NCT07485829 Zimmer Biomet-RibFix Titan RECRUITING NCT02759744 Fusion Guided Focal Laser Ablation of Prostate Cancer ENROLLING_BY_INVITATION

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.

↑