FDA.report

510(k) K253611

Device
Falco Fusion System
Applicant
Mcnicoll Surgical, Inc.
510(k) number
K253611
Product code
OUR
Decision
Substantially Equivalent (SESE)
Decision date
2026-01-29
Date received
2025-11-18
Regulation
888.3040
Classification name
Sacroiliac Joint Fixation
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Etienne Robichaud
Address
702-1750 Ave. De Vitre Quebec City CA G1J1Z6 G1J1Z6

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code OUR

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K250247panaSIa SI Fusion SystemWenzel Spine, Inc.2025-07-09
K251395The Rialto™ SI Fusion SystemMedtronic Sofamor Danek USA, Inc.2025-06-26
K251525SI-TECHNOLOGY® SI-DESIS® X™ Sacroiliac Joint Fusion SystemSi-Technology, LLC2025-06-06
K242431Omnia Medical PsiF DNA™ SystemOmnia Medical, LLC2025-06-06
K250001Patriot SI Implant SystemSpinal Simplicity, LLC2025-06-03
K251075DYNAMIS™ Implant SystemPromethean Restorative, LLC2025-04-25
K250403Catamaran SI Joint Fusion SystemTenon Medical2025-03-21