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Orthofix

FDA UDI

Class II (US FDA UDI)

by Orthofix, Inc.

Identity

Trade Name
ORTHOFIX FDA UDI
Generic Name
Long bone distraction intramedullary nail, motorized FDA UDI
Device Name
FITBONE TROCHANTERIC NAIL L285MM D9MM STERILE FDA UDI
Model / Reference
1 FDA UDI
Description
FITBONE TROCHANTERIC NAIL L285MM D9MM STERILE FDA UDI

Identifiers

Catalog Number
99-709285 FDA UDI
Primary DI / UDI-DI
18059015373677 FDA UDI
510(k) Number
K233867 FDA UDI
FDA Product Code
HSB FDA UDI
GMDN Term
Long bone distraction intramedullary nail, motorized 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

Yes

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
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 9 Millimeter FDA UDI
Outer Diameter — 10 Millimeter FDA UDI
Length — 285 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 fbe1ed62-827a-4a2d-98cf-d220c332e08e 38 fields · synced Jun 6, 2026