Flow-Nail™

FDA UDI

Class II (US FDA UDI)

by Flow-Fx, LLC

Identity

Trade Name: Flow-Nail™ FDA UDI
Generic Name: Femur nail, non-sterile FDA UDI
Device Name: Flow-Nail Guidewire (3.2mm) FDA UDI
Model / Reference: 101-06 FDA UDI
Description: Flow-Nail Guidewire (3.2mm) FDA UDI

Identifiers

Catalog Number: 101-06 FDA UDI
Primary DI / UDI-DI: B267101061 FDA UDI
510(k) Number: K140601 FDA UDI
FDA Product Code: HSB FDA UDI
GMDN Term: Femur nail, non-sterile FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3020 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Femur nail, non-sterile

Flow-Nail™ by Flow-Fx, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Femur nail, non-sterile.

OIC Intramedullary Nail System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
GALILEO® TROCHANTERIC NAIL, LEFT, Ø10mm x 30cm x 130° — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II
AOS ANTEGRADE FEMORAL NAIL, LEFT 13mm x 46cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II
AIM™FEMORAL NAIL — Biomet Orthopedics, Inc. · Class II
Syntec Femoral Nail System — Syntec Scientific Corp. · Class II
AOS ES™ TROCHANTERIC NAIL, RIGHT 12.5mm x 39cm x 125° — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II
AOS ANTEGRADE FEMORAL NAIL, RIGHT 9mm x 28cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II
AOS MODULAR NAIL 13.0mm x 46cm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II

Cleared under the same submission

K140601 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Flow-Fx, LLC

Sources (1)

FDA UDI da87f2bc-1a29-494f-b5e6-b25dc9db3f92 35 fields · synced May 30, 2026