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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, single-use FDA UDI
Device Name
FITBONE TRANSPORT TRIAL NAIL TN 1360-F-R-370 STERILE FDA UDI
Model / Reference
1 FDA UDI
Description
FITBONE TRANSPORT TRIAL NAIL TN 1360-F-R-370 STERILE FDA UDI

Identifiers

Catalog Number
99-60003803 FDA UDI
Primary DI / UDI-DI
18059015372755 FDA UDI
510(k) Number
K232169 FDA UDI
FDA Product Code
HSB FDA UDI
GMDN Term
Bone nail trial, single-use 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

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Length — 370 Millimeter FDA UDI
Outer Diameter — 13 Millimeter FDA UDI

Category: Bone nail trial, single-use

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

Similar devices

Also classified as Bone nail trial, single-use.

Cleared under the same submission

K232169 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 57c32ae9-9b70-497e-b2fc-18475f94d66d 37 fields · synced Jun 8, 2026