Orthoxel

FDA Filings

This page includes the latest FDA filings for Orthoxel. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Orthoxel holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

ORTHOXEL

FDA Registration(s)

Registration Number

3014976005

FEI Number

3014976005

Name

ORTHOXEL

Owner & Operator

OrthoXel

Contact Address

Rubicon Centre Bishopstown
Cork IE-NOTA T12 Y275 IE

Official Correspondent

Aisling O'Sullivan
353-21-2429500-x

US Agent

Hollace Saas Rhodes
Musculoskeletal Clinical Regulatory Advisers
202 5525807
hrhodes@mcra.com

Importing Logistics Registration

Importer	OrthoXel
	985596830
Address	Rubicon Centre Bishopstown Cork, T12 Y275 IRELAND
Email Address	regulatory@orthoxel.com
Phone	353 21 2429500
Importer Type	Manufacturer
Subdivision	IE-M

Registration Status

Initial Importer

Registration Expiration

2020-04-25

Registration Address

Rubicon Centre Bishopstown
Cork, T12 Y275 IE

Establishment Type

Develop Specifications But Do Not Manufacture At This Facility

FDA Filings

Device Company	Device	Date
LXH ORTHOXEL	Apex Tibial Nailing System Instrumention	2019-09-26
HXX ORTHOXEL	Apex Tibial Nailing System Instrumention	2019-09-26
HXI ORTHOXEL	Apex Tibial Nailing System Instrumentation	2019-09-26
HXC ORTHOXEL	Apex Tibial Nailing System Instrumentation	2019-09-26
HWJ ORTHOXEL	Apex Tibial Nailing System Instrumentation	2019-09-26
HTW ORTHOXEL	Apex Tibial Nailing System Instrumentation	2019-09-26
HTO ORTHOXEL	Apex Tibial Nailing System Instrumentation	2019-09-26
PMN K170972 \| HWC ORTHOXEL	Apex Tibial Nailing System	2018-11-21
PMN K170972 \| HSB ORTHOXEL	Apex Tibial Nailing System	2018-11-21
PMN K181375 OrthoXel	Apex Femoral Nailing System	2018-07-17
PMN K170972 OrthoXel	Apex Tibial Nailing System	2017-12-20

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