Pro-X1

FDA UDI

Class II (US FDA UDI)

by X-Bolt Orthopedics

Identity

Trade Name: Pro-X1 FDA UDI
Generic Name: Femur intramedullary nail FDA UDI
Device Name: 375mm x Ø11.0mm, 125° Long Trochanteric Nail, Left FDA UDI
Model / Reference: XBT110375L FDA UDI
Description: 375mm x Ø11.0mm, 125° Long Trochanteric Nail, Left FDA UDI

Identifiers

Primary DI / UDI-DI: 05397283000540 FDA UDI
FDA Product Code: HSB FDA UDI
GMDN Term: Femur intramedullary nail 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

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Length — 375 Millimeter FDA UDI

Category: Femur intramedullary nail

Pro-X1 by X-Bolt Orthopedics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Femur intramedullary nail.

GAMMA — Stryker Corp. · Class II
A.R.T.™FEMORAL NAIL — Biomet Orthopedics, Inc. · Class II
T2 ALPHA — Stryker Corp. · Class II
PRECICE® Bone Transport System — NuVasive Specialized Orthopedics, Inc. · Class II
T2 — Stryker Corp. · Class II
130° Ga-mma Nail — Auxein Medical Private Limited · Class II
ARIX Femur Nail System — Jeil Medical Corporation · Class II
INTERTAN — Smith & Nephew, Inc. · Class II

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 II	Pending data

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Manufacturer

Manufacturer: X-Bolt Orthopedics

Sources (1)

FDA UDI 4cab388c-ccd7-4cb7-8d50-d590a6351156 34 fields · synced Jun 8, 2026