Flow-Nail

FDA 510(k) K140601 · Flow-Fx, LLC

Substantially Equivalent

510(k) numberK140601

Submission

Device name
Flow-Nail
Applicant
Flow-Fx, LLC
Washington, DC, US
Received
March 10, 2014
Decision date
July 2, 2014
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
HSB – Rod, Fixation, Intramedullary And Accessories
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3020
Specialty
Orthopedic
Implant
Yes

Other 510(k)s with product code HSB

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K261481Pangea Femur Reconstruction SystemHSB · Traditional Stryker GmbH06/29/2026SE
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K253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)HSB · Traditional Suzhou and Science & Technology Development Corp.06/18/2026SE
K253155Fule Metallic Lockable Intramedullary Nail SystemsHSB · Traditional Beijing Fule Science & Technology Development…06/17/2026SE
K253046HERA Interlocking Intramedullary Nailing SystemHSB · Traditional ZheJiang Decans Medical Devices Co., Ltd.06/16/2026SE
K260146Fitbone® Transport and Lengthening SystemHSB · Traditional Orthofix Srl05/19/2026SE
K253991Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAAHSB · Traditional Orthofix Srl05/08/2026SE
K261043AUTOBAHN™ Nailing SystemHSB · Special Globus Medical, Inc.04/24/2026SE
K252016Arthrex Humeral NailsHSB · Traditional Arthrex, Inc.03/20/2026SE
K252961Fusion FibFix NailHSB · Traditional Fusion Orthopedics USA, LLC03/18/2026SE

More from Fusion Orthopedics USA, LLC

510(k)DeviceDecision
K234075Flow-NailHSB · Special 02/05/2024SE
K221115Flow-NailHSB · Special 05/13/2022SE
K142776Flow-ScrewHWC · Traditional 03/23/2015SE

Questions and answers

When was Flow-Nail cleared by the FDA?

Flow-Nail (K140601) received a 510(k) decision of Substantially Equivalent on July 2, 2014, 114 days after the submission was received.

What is the product code of K140601?

The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.