Orthofix

FDA UDI

Class I (US FDA UDI)

by Orthofix, Inc.

Identity

Trade Name: ORTHOFIX FDA UDI
Generic Name: Medical ruler, reusable FDA UDI
Device Name: FITBONE TLN SCREW OVERLAY FDA UDI
Model / Reference: 1 FDA UDI
Description: FITBONE TLN SCREW OVERLAY FDA UDI

Identifiers

Catalog Number: 60003517 FDA UDI
Primary DI / UDI-DI: 18059015372908 FDA UDI
FDA Product Code: FTY FDA UDI
GMDN Term: Medical ruler, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 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

Yes

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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Medical ruler, reusable

Orthofix by Orthofix, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 I	Pending data

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Manufacturer

Manufacturer: Orthofix, Inc.

Sources (1)

FDA UDI 408210cf-422d-46b4-b179-662d3077e39b 35 fields · synced May 30, 2026