Microware Bone Plates and Bone Screws

FDA UDI

Class II (US FDA UDI)

by Microware Precision Co., Ltd.

Identity

Trade Name: Microware Bone Plates and Bone Screws FDA UDI
Generic Name: Orthopaedic bone screw (non-sliding) FDA UDI
Device Name: CORTEX SCREW 4.5mm x 64mm, HEXAGON SOCKET, SELF-TAPPING, 3 FLUTES FDA UDI
Model / Reference: 214864E-000 FDA UDI
Description: CORTEX SCREW 4.5mm x 64mm, HEXAGON SOCKET, SELF-TAPPING, 3 FLUTES FDA UDI

Identifiers

Primary DI / UDI-DI: 04719872224204 FDA UDI
510(k) Number: K111008 FDA UDI
FDA Product Code: HWC FDA UDI
GMDN Term: Orthopaedic bone screw (non-sliding) FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic bone screw (non-sliding)

Microware Bone Plates and Bone Screws are orthopedic bone fixation solutions that provide stable and secure healing for fractured bones. These screws are designed to be inserted into the bone using a screwdriver, allowing for direct interfragmentary stabilization of the fractured bone.

Similar devices

Also classified as Orthopaedic bone screw (non-sliding).

EVOS — Smith & Nephew, Inc. · Class II
TriLeap Lower Extremity Anatomic Plating System — CROSSROADS EXTREMITY SYSTEMS LLC · Class II
Arthrex® — Arthrex, Inc. · Class II
Zavation — ZAVATION · Class II
STARDRIVE — Synthes GmbH · Class IIb
Arthrex® — Arthrex, Inc. · Class II
Cancellous Screw, Locking — I.T.S. GmbH · Class II
PANGEA — Stryker Corp. · Class II

Cleared under the same submission

K111008 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: Microware Precision Co., Ltd.

Sources (1)

FDA UDI 88b48a4f-8ada-4aab-a893-a8f38c8ae6f7 35 fields · synced Jul 15, 2026