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FDA UDI

Class II (US FDA UDI)

by Orthofix US LLC

Identity

Trade Name
ICON FDA UDI
Generic Name
Bone-screw internal spinal fixation system FDA UDI
Device Name
4.5mm x 55mm Multi-Axial Screw FDA UDI
Model / Reference
54-3455 FDA UDI
Description
4.5mm x 55mm Multi-Axial Screw FDA UDI

Identifiers

Primary DI / UDI-DI
18257200051717 FDA UDI
510(k) Number
K111448 FDA UDI
FDA Product Code
NKB FDA UDI
GMDN Term
Bone-screw internal spinal fixation system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3070 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 4.5 Millimeter FDA UDI
Length — 55 Millimeter FDA UDI

Category: Bone-screw internal spinal fixation system

Icon by Orthofix US LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone-screw internal spinal fixation system.

Cleared under the same submission

K111448 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Orthofix US LLC

Sources (1)

  • FDA UDI f704d12c-3824-4bde-8375-86f34d79bc00 36 fields · synced Jun 6, 2026