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Orthofix

FDA UDI

Class II (US FDA UDI)

by Orthofix, Inc.

Identity

Trade Name
ORTHOFIX FDA UDI
Generic Name
Bone nail trial, reusable FDA UDI
Device Name
FITBONE TROCHANTERIC TRIAL NAIL L305MM D11MM FDA UDI
Model / Reference
1 FDA UDI
Description
FITBONE TROCHANTERIC TRIAL NAIL L305MM D11MM FDA UDI

Identifiers

Catalog Number
7001305 FDA UDI
Primary DI / UDI-DI
18052469476697 FDA UDI
510(k) Number
K233867 FDA UDI
FDA Product Code
HSB FDA UDI
GMDN Term
Bone nail trial, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3020 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 11 Millimeter FDA UDI
Length — 305 Millimeter FDA UDI

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

Cleared under the same submission

K233867 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Orthofix, Inc.

Sources (1)

  • FDA UDI 4a2a6cef-d91a-4a7f-ab7b-79216a4e250d 38 fields · synced May 31, 2026