Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010329663

FEI Number

3010329663

Entity Name

IONISOS Pouzauges

City/State/Country

Pouzauges Vendee, FR

Establishment Address

ZI de Montifaut, Pouzauges Vendee 85700, FR

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

EPIONE BIDCO (Owner Number: 10042490)

Owner / Operator Contact Address

415 allee de Frenes, bat Squale, LIMONEST, FR-69 69760, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Universal Distal Radius System Footmotion HammerToe Xpert Wrist Romero Cervical Cage Activmotion S DTO Bony Trauma Extremity System (BTES) Screw Range - NX Nail System High Tibial Osteostomy System Large Screws Range Alians Clavicle Range DTS2, Distal Radius Locking Plating System Large Screw System Xpert Hand SternaFuse Fixation System Activ Fuse Activ Ankle Foot and Hand Motion System GoLIF! Lumbar Interbody Fusion System Alians Elbow Plating System Xpert Knee Activmotion S Humerus Locking Plating System Vial Adapter o13mm Without Filter Vial Adapter o13mm Filter 5um Vial Adapter O13mm Filter 15um Set, i.v. fluid transfer Activ Ankle Locking Plating System Alians Elbow Locking Plating System Footmotion Plating System GoPLF! Posterior Lateral Fusion System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-01-31
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-01-31
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2022-01-31
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-12-21
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-12-21
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2022-09-08
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-01-29
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-01-29
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-04-14
QRL	Multiple Use Blood Lancet For Single Patient Use Only	General, Plastic Surgery	Class 2	878.4850	2023-07-13
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-01-31
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-01-31
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-01-31
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-01-31
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-01-31
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-01-31
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-01-31
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-01-31
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2026-04-07
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2026-04-07
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-09-08
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-01-31
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-01-31
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-01-31
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-01-31
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-01-31
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-04-14
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-01-31
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-01-31
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2026-04-07
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2026-04-07
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-01-29
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-01-29
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-01-31
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-01-31
LHI	Set, I.V. Fluid Transfer	General Hospital	Class 2	880.5440	2023-01-03
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-01-31
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-01-31
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-01-31
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-01-31
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-12-21
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-12-21
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2022-09-08

Official Correspondent

Alexandra Basset

US Agent Details

Stephan Toupin Business: Dawa Medical LLC Email: stoupin@dawamedical.com Phone: (786) 7311159

Related Public Records

Same Entity

EPIONE BIDCO

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

View Entity Profile →

Other Registrations for Same Entity

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3010191069	IONISOS	Tarancon Cuenca, ES
3003617485	Ionisos Baltics OU	Saue vald Harjumaa, EE
3003775072	IONISOS	CHAUMESNIL Grand Est, FR
3002807295	IONISOS	SABLE-SUR-SARTHE, FR
3010178296	IONISOS	Dagneux Ain, FR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K062348	Medtronic Neurosurgery	TIMESH SELF DRILLING SCREW	2006-09-08
K063244	Arc Surgical, LLC	ARC SURGICAL BONE REDUCTION SCREW	2006-12-27
K972722	Orthopedic Designs, Inc.	ULTIMATE COMPRESSION SCREW SYSTEM	1998-01-23
K192974	Tyber Medical, LLC	Tyber Medical Trauma Screw	2020-01-08
K082949	OrthoPediatrics Corp.	ORTHOPEDIATRICS BONE SCREWS	2008-11-25

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0014-2014	Synthes USA HQ, Inc.	2	Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016	Ortho Solutions Inc 330 Franklin Tnpk	2	Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013	Orthohelix Surgical Designs Inc	2	OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0043-2018	MicroPort Orthopedics Inc.	2	MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010329663. Last updated year: 2026. Please use registration number 3010329663 when referencing this establishment in official correspondence.