Pro-X1

FDA UDI

Class II (US FDA UDI)

by X-Bolt Orthopedics

Identity

Trade Name: Pro-X1 FDA UDI
Generic Name: Medullary canal orthopaedic reamer, rigid FDA UDI
Device Name: Conical Reamer FDA UDI
Model / Reference: XNI-006 FDA UDI
Description: Conical Reamer FDA UDI

Identifiers

Primary DI / UDI-DI: 05397283000069 FDA UDI
FDA Product Code: HSB FDA UDI
GMDN Term: Medullary canal orthopaedic reamer, rigid 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

Yes

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: Medullary canal orthopaedic reamer, rigid

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

Similar devices

Also classified as Medullary canal orthopaedic reamer, rigid.

POLARSTEM — Smith & Nephew, Inc. · Class II
Intramedullary Reamer, Revision — TOTAL JOINT ORTHOPEDICS, INC. · Class I
INSTRUMENT — Howmedica Osteonics Corp. · Class I
Comprehensive® Shoulder Instruments — Biomet Orthopedics, Inc. · Class II
MP Reconstruction System - Instruments — WALDEMAR LINK GmbH & Co. KG · Class I
Panta® 2 — Ascension Orthopedics, Inc. · Class I
Legion — Smith & Nephew, Inc. · Class II
INSTRUMENT — Howmedica Osteonics Corp. · Class I

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: X-Bolt Orthopedics

Sources (1)

FDA UDI 9fea00f3-2baf-4537-94b2-2362eaf709f6 33 fields · synced Jun 8, 2026