IONISOS

FDA Device Registration & Listing · SABLE-SUR-SARTHE, FR · Registration 3002807295

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3002807295
FEI Number
3002807295
Entity Name
IONISOS
City/State/Country
SABLE-SUR-SARTHE, FR
Establishment Address
Z.A de L Aubree, SABLE-SUR-SARTHE 72300, 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
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

CORAIL REVISION STEM CORAIL DXTEND MODULAR HUM STEM DXTEND MOD EPI CMI AEQUALIS GLENOID Symbotex™ Composite Mesh RHS - RADIAL PROSTHESIS CEMENT RESTRICTOR AEQUALIS REVERSED FRACTURE CRF II - RADIAL PROSTHESIS CEMENT RESTRICTOR AEQUALIS REVERSED DXTEND HIGHMO PE CUP Versatex™ Monofilament Mesh CEMENT RESTRICTOR DIACLEAR ULTRAFILTER AEQUALIS RESURFACING HEAD BI-MENTUM dual mobility system Parietex Composite (PCO-OS) Parietex Composite Parietex Optimized Composite Mesh (PCOX) Parietex Optimized Composite Mesh (PCO-FX) Parietex Parietex Optimized Composite Mesh (PCO-OSX) Parietex™ Hydrophilic 2-Dimensional Mesh Parietex™ Hydrophilic Anatomical Mesh Parietex™ Hydrophilic 3-Dimensional Mesh DELTA SHOULDER TETE HUM INOX DELT DELTA SHOULDER Tornier Perform Anatomic Glenoid Tornier Flex Shoulder System AEQUALIS REVERSED AEQUALIS REVERSED II AEQUALIS REVERSED AEQUALIS REVERSED AEQUALIS REVERSED II AEQUALIS GLENOID & REVERSED TORNIER - DRILL BIT AEQUALIS RESURFACING HEAD DXTEND GLENOSPHERE DXTEND METAGLENE DXTEND MBLOC HUM EPI DXTEND SCREW LOCK DXTEND CTA HEAD DXTEND SCREW NO LOCK DXTEND RETENT PE CUP DXTEND HUMERAL SPACER DXTEND IMP HUM CIM DXTEND STAND PE CUP AEQUALIS REVERSED AEQUALIS REVERSED II Tornier Flex Shoulder System DELTA SHOULDER EmboCube Embolization Gelatin AEQUALIS PRESS-FIT AEQUALIS REVERSED AEQUALIS GLENOID Tornier Flex Shoulder System AEQUALIS-FRACTURE 611 - ANKLE FUSION NAIL Torpedo Gelatin Foam DELTA SHOULDER CUP HUMERALE PE CUP AEQUALIS REVERSED II AEQUALIS PRESS-FIT Symbotex™ Composite Mesh Parietex™ Composite Parastomal Mesh

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2021-04-08
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2021-04-08
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2021-01-29
KWL Prosthesis, Hip, Hemi-, Femoral, Metal Orthopedic Class 2 888.3360 2021-01-29
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2021-01-29
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-01-28
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2021-01-28
KYI Prosthesis, Wrist, Carpal Trapezium Orthopedic Class 2 888.3770 2013-02-01
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2013-02-01
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2013-02-01
JDB Prosthesis, Elbow, Semi-Constrained, Cemented Orthopedic Class 2 888.3160 2013-02-01
JDC Prosthesis, Elbow, Constrained, Cemented Orthopedic Class 2 888.3150 2013-02-01
OXJ Mesh, Surgical, Non-Absorbable, Large Abdominal Wall Defects General, Plastic Surgery Class 2 878.3300 2013-11-25
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2013-11-25
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-02-26
JDB Prosthesis, Elbow, Semi-Constrained, Cemented Orthopedic Class 2 888.3160 2013-02-01
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2013-01-31
JDB Prosthesis, Elbow, Semi-Constrained, Cemented Orthopedic Class 2 888.3160 2013-02-01
JDC Prosthesis, Elbow, Constrained, Cemented Orthopedic Class 2 888.3150 2013-02-01
JDC Prosthesis, Elbow, Constrained, Cemented Orthopedic Class 2 888.3150 2013-02-01
JDB Prosthesis, Elbow, Semi-Constrained, Cemented Orthopedic Class 2 888.3160 2013-02-01
LZN Cement Obturator General, Plastic Surgery Class 2 878.3300 2013-01-31
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2013-01-31
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2019-07-24
KWI Prosthesis, Elbow, Hemi-, Radial, Polymer Orthopedic Class 2 888.3170 2013-02-01
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2021-01-06
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2013-02-01
JDC Prosthesis, Elbow, Constrained, Cemented Orthopedic Class 2 888.3150 2013-02-01
JDB Prosthesis, Elbow, Semi-Constrained, Cemented Orthopedic Class 2 888.3160 2013-02-01
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2024-01-24
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2024-01-24
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2015-06-03
JDB Prosthesis, Elbow, Semi-Constrained, Cemented Orthopedic Class 2 888.3160 2013-01-31
JDC Prosthesis, Elbow, Constrained, Cemented Orthopedic Class 2 888.3150 2013-01-31
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2013-02-01
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2013-02-01
NAJ Agents, Embolic, For Treatment Of Uterine Fibroids Cardiovascular Class 2 870.3300 2015-06-10
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2015-06-10
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2013-02-26
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2019-07-24
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2013-01-31
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2018-12-18
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2018-12-18
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2018-04-27
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2013-02-01
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2013-02-01
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2021-02-01
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-02-01
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2013-01-31
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2013-01-31
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2013-01-31
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-01-06
HAO Instrument, Surgical, Non-Powered Neurology Class 1 882.4535 2026-02-12
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2013-01-31
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2013-01-31
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2013-02-01
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2013-01-31
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2013-01-31
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2013-02-01
HTW Bit, Drill Orthopedic Class 1 888.4540 2013-11-18
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2021-01-28
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-01-28
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2013-01-31
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2021-01-06
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-01-06
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2021-01-06
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2021-01-06
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2021-01-29
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-01-29
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2021-01-29
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2021-01-06
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2013-02-01
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2013-02-01
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2013-02-01
JDZ Mixer, Cement, For Clinical Use Orthopedic Class 1 888.4210 2021-01-04
QKW Shoulder Joint Humeral (Hemi-Shoulder) Ceramic Head/Metallic Stem Cemented Or Uncemented Prosthesis Orthopedic Class 2 888.3695 2025-01-23
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2013-02-01
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2013-02-01
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2021-01-06
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2021-01-06
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2013-01-31
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2013-01-31
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2013-02-01
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2015-06-10
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-01-29
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-04-08
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2013-02-01
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2013-02-01
SFD In Situ Polymerizing Peripheral Nerve Repair Device Neurology Class 2 882.5270 2025-08-21
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2013-02-26
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2016-05-04
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2015-12-16
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2016-05-04
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2013-01-31
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2013-01-31
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2013-01-31

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

Registration Number Establishment Name Location
3010191069 IONISOS Tarancon Cuenca, ES
3003617485 Ionisos Baltics OU Saue vald Harjumaa, EE
3003775072 IONISOS CHAUMESNIL Grand Est, FR
3010329663 IONISOS Pouzauges Pouzauges Vendee, FR
3010178296 IONISOS Dagneux Ain, FR

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K042344 Aesculap, Inc. EXCIA TOTAL HIP SYSTEM 2005-03-16
K030151 Hayes Medical, Inc. CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM 2003-04-10
K153381 Corin U.S.A. Limited Corin Metafix Hip Stem 2016-01-21
K140975 Lima Corporate S.P.A. MASTERSL FEMORAL STEM 2014-06-10
K932222 Dow Corning Wright SLT FEMORAL HEAD 1994-05-27

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0023-06 Zimmer Inc. 2
Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604000.
Z-0024-06 Zimmer Inc. 2
Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604046.
Z-0025-06 Zimmer Inc. 2
Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604640.
Z-0026-06 Zimmer Inc. 2
Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604600.
Z-0027-06 Zimmer Inc. 2
Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 52 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604652.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3002807295. Last updated year: 2026. Please use registration number 3002807295 when referencing this establishment in official correspondence.
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