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Fitbone Trochanteric

FDA UDI

Class II (US FDA UDI)

by Orthofix, Inc.

Identity

Trade Name
Fitbone Trochanteric FDA UDI
Generic Name
Bone nail trial, reusable FDA UDI
Device Name
FITBONE TROCHANTERIC TRIAL NAIL L217MM D11MM FDA UDI
Model / Reference
1 FDA UDI
Description
FITBONE TROCHANTERIC TRIAL NAIL L217MM D11MM FDA UDI

Identifiers

Catalog Number
7001217 FDA UDI
Primary DI / UDI-DI
18059015376364 FDA UDI
510(k) Number
K250112 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
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

No

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 — 217 Millimeter FDA UDI

Category: Bone nail trial, reusable

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

Similar devices

Also classified as Bone nail trial, reusable.

Cleared under the same submission

K250112 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 1f693dff-8949-410d-b565-71dff1b7a4ca 37 fields · synced May 30, 2026