Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010368646

FEI Number

3010368646

Entity Name

X-BOLT ORTHOPEDICS

City/State/Country

Santry Dublin, IE

Establishment Address

Unit 5 Northwood Court, Santry Dublin D09AX54, IE

Establishment Type(s)

Manufacture Medical Device,Develop Specifications But Do Not Manufacture At This Facility,Export Device to the United States But Perform No Other Operation on Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

X-Bolt Orthopedics (Owner Number: 10085237)

Owner / Operator Contact Address

20802 Unison Rd., Roundhill, Round Hill, VA 20141, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K221621

PMA Number

N/A

All Registered Proprietary Names

X-Bolt Pro-X1®

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2022-05-23
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2022-05-23
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2023-12-06

Official Correspondent

Brian Thornes

US Agent Details

Sexton Ryan Business: MCRA Email: rsexton@mcra.com Phone: (732) 7707662

Related Public Records

Same Entity

X-Bolt Orthopedics

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K040336	Synthes (Usa)	SYNTHES (USA) LATERAL ENTRY FEMORAL NAIL SYSTEM	2004-04-12
K083648	Efratgo, Ltd. HI Tech Bio-Surgical	GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL	2009-05-14
K192312	Zimmer GmbH	Zimmer Natural Nail System Cephalomedullary Nails	2019-10-11
K002057	Biomet Orthopedics, Inc.	BROOKER TIBIA NAILS	2000-10-04
K033476	Howmedica Osteonics Corp.	MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM	2004-01-20

Similar Registrations

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3008599979	THE ORTHOPAEDIC IMPLANT COMPANY	Reno, NV, US
3006783837	STRUCTURE MEDICAL, LLC.	Naples, FL, US
3009732568	BGS BETA-GAMMA-SERVICE GMBH & CO KG	Wiehl North Rhine-Westphalia, DE
1424263	Isomedix Operations, Inc.	Libertyville, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010368646. Last updated year: 2026. Please use registration number 3010368646 when referencing this establishment in official correspondence.