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Flex-Thread Ulna

FDA UDI

Class II (US FDA UDI)

by Flower Orthopedics Corporation

Identity

Trade Name
Flex-Thread Ulna FDA UDI
Generic Name
General internal orthopaedic fixation system implantation kit FDA UDI
Device Name
Flex-Thread Ulna Nail, D: 5.5mm x 210mm FDA UDI
Model / Reference
FTU 521-S FDA UDI
Description
Flex-Thread Ulna Nail, D: 5.5mm x 210mm FDA UDI

Identifiers

Primary DI / UDI-DI
00840118119627 FDA UDI
FDA Product Code
HSB FDA UDI
GMDN Term
General internal orthopaedic fixation system implantation kit 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

Yes

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

No

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Radiation Sterilization FDA UDI

Category: General internal orthopaedic fixation system implantation kit

Flex-Thread Ulna by Flower Orthopedics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General internal orthopaedic fixation system implantation kit.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Flower Orthopedics Corporation

Sources (1)

  • FDA UDI 4bdba155-5303-4917-b4b8-30a1cc3ad396 34 fields · synced Jun 8, 2026