Flex-Thread

FDA UDI

Class I (US FDA UDI)

by Flower Orthopedics Corporation

Identity

Trade Name: Flex-Thread FDA UDI
Generic Name: Bone tack inserter, basic FDA UDI
Device Name: Plate Tack, 1.5mm x 48mm, Smooth FDA UDI
Model / Reference: KWS020 FDA UDI
Description: Plate Tack, 1.5mm x 48mm, Smooth FDA UDI

Identifiers

Primary DI / UDI-DI: 00840118121859 FDA UDI
FDA Product Code: HXI FDA UDI
GMDN Term: Bone tack inserter, basic FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

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: Bone tack inserter, basic

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

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Standard tip — MC BIO SRL · Class I
HALLMARK — Orthofix US LLC · Class I

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 I	Pending data

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Manufacturer

Manufacturer: Flower Orthopedics Corporation

Sources (1)

FDA UDI da93c642-fcfe-4e57-be5f-ae81ac1f9afb 34 fields · synced May 29, 2026