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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 24mm FDA UDI
Model / Reference
FX-CS-4024 FDA UDI
Description
Chamfered Screw 4.0mm x 24mm FDA UDI

Identifiers

Catalog Number
FX-CS-4024 FDA UDI
Primary DI / UDI-DI
00840124509061 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

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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

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 orthopaedic bone screws used for internal fixation of limb bones, ribs, sternum, and pelvis to hold plates, nails, rods or prostheses in place.

Similar devices

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

Cleared under the same submission

K170038 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fusion Orthopedics, Llc

Sources (1)

  • FDA UDI 6aa2b2de-26df-45b9-82eb-c1f833e80aa6 35 fields · synced Jul 17, 2026