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Flex Nail

FDA UDI

Class II (US FDA UDI)

by Fx Solutions

Identity

Trade Name
FLEX NAIL FDA UDI
Generic Name
Flexible bone nail, non-sterile FDA UDI
Device Name
FLEX NAIL TA6V Ø3.0mm L.450mm FDA UDI
Model / Reference
FX221.300 FDA UDI
Description
FLEX NAIL TA6V Ø3.0mm L.450mm FDA UDI

Identifiers

Catalog Number
FX221.300 FDA UDI
Primary DI / UDI-DI
03701037310786 FDA UDI
510(k) Number
K964243 FDA UDI
FDA Product Code
HSB FDA UDI
GMDN Term
Flexible bone 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Flexible bone nail, non-sterile

Flex Nail by Fx Solutions — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Flexible bone nail, non-sterile.

Cleared under the same submission

K964243 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fx Solutions

Sources (1)

  • FDA UDI 71e996a8-f4aa-4df8-85ed-89c30310c4f6 35 fields · synced May 30, 2026