Pro-X1

FDA UDI

Class II (US FDA UDI)

by X-Bolt Orthopedics

Identity

Trade Name: Pro-X1 FDA UDI
Generic Name: Surgical tamp, reusable FDA UDI
Device Name: Bone Crusher FDA UDI
Model / Reference: XNI-014 FDA UDI
Description: Bone Crusher FDA UDI

Identifiers

Primary DI / UDI-DI: 05397283000120 FDA UDI
FDA Product Code: HSB FDA UDI
GMDN Term: Surgical tamp, 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

FDA UDI

Single Use

FDA UDI

Implantable

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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical tamp, reusable

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

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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 7e3d6679-e8b7-4da2-a8c2-53e8b1f7a50f 33 fields · synced Jun 8, 2026