FuzeFix Chamfered Screws

FDA UDI

Class II (US FDA UDI)

by Fusion Orthopedics, Llc

Identity

Trade Name: FuzeFix Chamfered Screws FDA UDI
Generic Name: Orthopaedic bone screw (non-sliding) FDA UDI
Device Name: Chamfered Screw 4.0mm x 48mm FDA UDI
Model / Reference: FX-CS-4048 FDA UDI
Description: Chamfered Screw 4.0mm x 48mm FDA UDI

Identifiers

Catalog Number: FX-CS-4048 FDA UDI
Primary DI / UDI-DI: 00840124511330 FDA UDI
510(k) Number: K170038 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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic bone screw (non-sliding)

FuzeFix Chamfered Screws are a type of orthopaedic bone screw used for internal fixation in orthopedic procedures. These screws are designed to hold plates, nails, or rods in place, providing direct interfragmentary stabilization of fractured bones. With their unique design and features, FuzeFix Chamfered Screws are ideal for various surgical applications.

Similar devices

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

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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: Fusion Orthopedics, Llc

Sources (1)

FDA UDI 72bd6b8c-c82c-431b-93c5-1ccf0c559f4f 35 fields · synced Jul 16, 2026

FuzeFix Chamfered Screws

Identity

Identifiers

Classification

Clinical & Handling

Similar devices

Cleared under the same submission

Authorization Coverage (1 country)

Regulatory Authorizations

Manufacturer

Sources (1)