IONISOS

FDA Device Registration & Listing · Dagneux Ain, FR · Registration 3010178296

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
3010178296
FEI Number
3003110073
Entity Name
IONISOS
City/State/Country
Dagneux Ain, FR
Establishment Address
Parc Dombes Cotiere Activites, Dagneux Ain 01120, 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

AEQUALIS RESURFACING HEAD CEMSTOP Humelock Reversed Shoulder PIT’Stop® implant I.B.S.® Osteosynthesis screw AEQUALIS REVERSED ADAPTER AEQUALIS REVERSED FX / ADAPTER AEQUALIS REVERSED II Tornier Flex Shoulder System W-Bone Wishbone HA Bionnovation Oss XB DXTEND HIGHMO PE CUP Tornier Flex Shoulder System Avenir Muller Stem Ceramic Femoral Heads Avenir Muller Stem Exofix Opacity+ 32mm Glenosphere and Humeral Cup Ultima HA Coated Half Pins And Wire Orthex Extrenal-Fixation HA Half-Pins TOEGRIP® DIACLEAR ULTRAFILTER Easytech Anatomical Shoulder System Humeral Cup Stability AEQUALIS REVERSED FRACTURE Symbotex™ Composite Mesh CORAIL Humelock II Cementless Shoulder System ARROW Short Stem Humeral System Zimmer Biomet Ceramic Heads I.B.S.™ Osteosynthesis screw Tornier Perform Reversed MonoPost Glenoid In2Bones® Kirschner wire CEMENT RESTRICTOR MOBI-C P&F US Permacol™ Surgical Implant, 0.5mm thick ENDURAGen™ Collagen Implant ZNN CMN Nails Humeris® 135° Sholder System Avenir Complete Hip System AEQUALIS REVERSED AEQUALIS REVERSED Inflation System CoLS BROCHE 23CM 2,4MM BOUT MECHE BOUT ROND (Teknomedical) MIS II AEQUALIS GLENOID & REVERSED AEQUALIS RESURFACING HEAD AEQUALIS REVERSED II powered screwdrivers tips AEQUALIS REVERSED TORNIER - DRILL BIT Ceramic Femoral Heads TELEGRAPH EVOLUTION Zimmer Biomet Ceramic Heads DELTA SHOULDER JARVIS Glenoid Reverse Shoulder Prosthesis Parietex™ Hydrophilic Anatomical Mesh Versatex™ Monofilament Mesh Parietex™ Hydrophilic 3-Dimensional Mesh Parietex™ Hydrophilic 2-Dimensional Mesh Symbotex™ Composite Mesh TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System BePOD ARTHRODESIS 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 CUP HUMERALE ARROW ANATOMICAL and REVERSE Porous ARROW OS2®-VP Varisation Staple Humelock Cemented Shoulder System CORAIL2 STD SZ6 Permacol™ Surgical Implant, 1mm/1.5mm thick CoLS CoLS PEEK 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 RHS - RADIAL PROSTHESIS Glenoid Baseplate with Screw EmboCube Embolization Gelatin FX V135 Shoulder Prosthesis I-STOP AEQUALIS REVERSED Lateralized and Augmented Baseplates Biolox® delta Option Ceramic Head Biolox® delta Ceramic Head Tornier Perform Anatomic Glenoid ARROW Off-Centred Humeral Insert I.B.S.™ 2 Osteosynthesis screw Drill bits (reamer) CRF II - RADIAL PROSTHESIS BePOD PERCUTANEOUS BePOD 3A CALCANAIL Humelock II Cemented Shoulder System CMI Lateralized and Augmented Baseplates TOUCH® CMC 1 Humeris Shoulder FX V135™ Additional Humeral Stems AEQUALIS REVERSED II Neosys single use kits Neomis single use kit ( except Neomis standard UK) Duafit single use kits DUAFIT® interphalangeal implant AEQUALIS GLENOID TiN Coated Humeral Head ARROW ANATOMICAL and REVERSE Porous ARROW Humeral Stem CEMENT RESTRICTOR Tornier Flex Shoulder System Anthogyr AXIOM® BL X3 implants Anthogyr Multi-Unit components for AXIOM® BL ARROW REVERSE shoulder long and short keel F20 Zimmer Biomet Ceramic Heads AEQUALIS REVERSED II AEQUALIS GLENOID & REVERSED TORNIER - DRILL BIT AEQUALIS RESURFACING HEAD Avenir Complete Hip System, Size 0 Coxa Vara CORAIL Permacol™ Surgical Implant, 1mm/1.5mm thick I-STOP TOMS HEMOBLAST™ Bellows Laparoscopic Applicator HEMOBLAST™ Bellows Zimmer Biomet Ceramic Heads AEQUALIS REVERSED II AEQUALIS REVERSED DXTEND MODULAR HUM STEM DXTEND MOD EPI Ultima HA Coated Half Pins And Wire Orthex Extrenal-Fixation HA Half-Pins AEQUALIS-FRACTURE BePOD EZ WEIL ARROW ANATOMIC and REVERSE shoulder system ARROW REVERSE shoulder system axiom BL reg Talos C HA Humelock II Cemented Reversible Shoulder AEQUALIS Neofuse screws (V35, V45) Ankle Fusion Plating System (Neofuse) CORAIL REVISION STEM Quadrasphere Microspheres axiom BL reg

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2013-01-31
LZN Cement Obturator General, Plastic Surgery Class 2 878.3300 2022-01-28
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2017-06-07
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2017-06-07
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2021-01-12
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2021-01-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-01-28
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2024-02-01
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-01-28
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2022-12-28
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2013-01-31
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2022-12-28
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
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
PEK Spinous Process Plate Orthopedic Class 2 888.3050 2021-01-12
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2021-01-12
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2021-01-12
SFD In Situ Polymerizing Peripheral Nerve Repair Device Neurology Class 2 882.5270 2025-08-21
NPM Bone Grafting Material, Animal Source Dental Class 2 872.3930 2024-01-24
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
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2021-01-13
ORG Platelet And Plasma Separator For Bone Graft Handling Hematology Class 2 864.9245 2022-01-27
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2021-01-12
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2021-01-12
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2021-01-12
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2022-01-28
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-01-06
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2026-05-11
KWL Prosthesis, Hip, Hemi-, Femoral, Metal Orthopedic Class 2 888.3360 2026-05-11
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2026-05-11
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2026-05-11
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2026-05-11
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2026-05-11
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-01-12
FRO Dressing, Wound, Drug Unknown Class U N/A 2012-12-13
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2021-01-12
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2021-01-12
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2021-01-12
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2025-04-29
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2025-04-29
KWL Prosthesis, Hip, Hemi-, Femoral, Metal Orthopedic Class 2 888.3360 2025-04-29
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2025-04-29
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2025-04-29
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2025-04-29
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2021-01-12
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2021-01-12
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2022-01-28
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2021-01-15
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2021-01-15
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2021-01-15
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2024-01-31
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2021-01-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2021-01-12
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2021-01-12
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2021-01-12
FIP Subsystem, Water Purification Gastroenterology, Urology Class 2 876.5665 2013-02-01
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2021-01-12
PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained Orthopedic Class 2 888.3660 2021-02-24
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2021-01-15
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2021-01-15
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2021-01-15
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2022-12-28
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2022-12-28
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2013-01-31
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
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2021-01-29
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2021-01-29
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2021-01-29
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2016-06-07
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2024-01-24
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2024-01-24
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2024-01-24
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2026-05-15
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2026-05-15
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2026-05-15
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-01-28
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2026-04-08
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2026-04-08
HTY Pin, Fixation, Smooth Orthopedic Class 2 888.3040 2022-01-28
JDW Pin, Fixation, Threaded Orthopedic Class 2 888.3040 2022-01-28
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
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2021-01-06
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2022-12-28
MJO Prosthesis, Intervertebral Disc Unknown Class 3 N/A 2023-01-30
FTM Mesh, Surgical General, Plastic Surgery Class 2 878.3300 2014-07-28
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2026-05-11
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2024-01-22
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2024-01-22
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2024-01-22
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-01-12
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2026-05-15
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2026-05-15
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2026-05-15
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2026-05-15
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2026-05-15
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2013-02-01
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2013-01-31
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2013-01-31
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2017-12-21
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2021-01-04
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2025-04-29
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2022-12-28
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-01-12
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2021-01-28
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2026-05-15
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2026-05-15
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2026-05-15
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2022-12-28
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 2025-08-22
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2025-08-22
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2025-08-22
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2022-12-21
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2022-01-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-01-28
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2021-01-13
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2021-01-13
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-01-28
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2018-04-27
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-03-20
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2025-03-20
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2013-01-31
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2021-01-28
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2021-01-28
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-01-28
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2022-01-28
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2016-06-07
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2012-12-03
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2012-12-03
OXK Mesh, Surgical, Collagen, Large Abdominal Wall Defects General, Plastic Surgery Class 2 878.3300 2014-07-28
FTM Mesh, Surgical General, Plastic Surgery Class 2 878.3300 2014-07-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-12-20
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
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 2021-01-15
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2021-01-15
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2021-01-12
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2021-01-06
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2021-01-13
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2021-01-13
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2025-03-20
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2025-03-20
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2022-07-01
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2022-07-01
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2022-07-01
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2021-01-12
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2021-01-12
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2021-01-12
OTN Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator General, Plastic Surgery Class 2 878.3300 2013-01-31
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-01-13
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2021-01-13
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2013-02-01
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2022-01-28
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2022-01-28
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2021-01-12
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2021-01-12
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2021-01-12
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-01-12
OQG Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented Orthopedic Class 2 888.3358 2026-05-15
OQI Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented Orthopedic Class 2 888.3353 2026-05-15
JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented Orthopedic Class 2 888.3350 2026-05-15
OQH Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented Orthopedic Class 2 888.3350 2026-05-15
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2026-05-15
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2026-05-15
LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented Orthopedic Class 2 888.3358 2026-05-15
MAY Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish Orthopedic Class 2 888.3353 2026-05-15
QHQ Total Shoulder Arthroplasty System Orthopedic Class 2 888.3660 2024-01-24
PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained Orthopedic Class 2 888.3660 2024-01-24
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2022-12-28
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2022-12-28
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 2024-01-24
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-01-12
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2021-01-12
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2021-01-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-01-28
GFG Bit, Surgical General, Plastic Surgery Class 1 878.4820 2021-01-26
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
KWI Prosthesis, Elbow, Hemi-, Radial, Polymer Orthopedic Class 2 888.3170 2013-02-01
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-01-28
HSB Rod, Fixation, Intramedullary And Accessories Orthopedic Class 2 888.3020 2021-01-28
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2023-01-30
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2016-06-07
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2016-06-07
KYI Prosthesis, Wrist, Carpal Trapezium Orthopedic Class 2 888.3770 2013-02-01
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2026-01-19
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2026-01-19
QHQ Total Shoulder Arthroplasty System Orthopedic Class 2 888.3660 2022-12-28
PKC Prosthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-Constrained Orthopedic Class 2 888.3660 2022-12-28
SFA Prosthesis, Finger, Semi-Constrained, Metal/Polymer Unknown Class 3 N/A 2025-07-21
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2022-01-28
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2022-01-28
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2017-06-07
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2017-06-07
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2017-06-07
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2024-01-22
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2024-01-22
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2024-01-22
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2021-01-13
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-01-13
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-04-08
KDD Kit, Surgical Instrument, Disposable General, Plastic Surgery Class 1 878.4800 2021-01-26
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-01-28
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 2021-01-15
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2021-01-15
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2021-01-28
MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3670 2021-01-28
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-01-28
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2021-01-12
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2021-01-28
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2021-01-28
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2021-01-28
LZN Cement Obturator General, Plastic Surgery Class 2 878.3300 2013-01-31
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2021-01-06
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
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2024-01-22
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2024-01-22
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2021-01-28
NDN Cement, Bone, Vertebroplasty Orthopedic Class 2 888.3027 2022-01-28
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2026-05-15
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2026-05-15
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2026-05-15
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-01-12
HTW Bit, Drill Orthopedic Class 1 888.4540 2013-11-18
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2022-01-28
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2026-05-15
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2026-05-15
LWJ Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented Orthopedic Class 2 888.3360 2026-05-15
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2026-05-15
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2026-05-15
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
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-01-12
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-01-13
FTL Mesh, Surgical, Polymeric General, Plastic Surgery Class 2 878.3300 2014-07-28
OTM Mesh, Surgical, For Stress Urinary Incontinence, Male General, Plastic Surgery Class 2 878.3300 2013-01-31
PMX Absorbable Collagen Hemostatic Agent With Thrombin General, Plastic Surgery Class 3 878.4490 2022-01-27
KWZ Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer Orthopedic Class 2 888.3310 2026-05-15
KWY Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented Orthopedic Class 2 888.3390 2026-05-15
LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented Orthopedic Class 2 888.3353 2026-05-15
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 2013-01-31
HSD Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented Orthopedic Class 2 888.3690 2013-01-31
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2013-01-31
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2025-03-20
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-03-20
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
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2024-01-31
OSN Software For Diagnosis/Treatment Orthopedic Class 2 888.3030 2024-01-31
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 2013-02-01
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2021-01-28
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2022-01-28
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2022-01-28
MQX Needle, Acupuncture, Single Use General Hospital Class 2 880.5580 2021-01-06
KWT Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3650 2013-12-20
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2013-12-20
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2013-12-20
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2013-02-01
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-01-13
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2021-01-26
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2021-01-12
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2022-12-28
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2022-12-28
PHX Shoulder Prosthesis, Reverse Configuration Orthopedic Class 2 888.3660 2016-06-07
KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3540 2013-01-31
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2013-02-01
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2022-01-28
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-01-28
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 2022-01-28
MEH Prosthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate Orthopedic Class 2 888.3353 2022-01-28
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2022-12-28
KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented Orthopedic Class 2 888.3660 2022-12-28
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-01-12
KRD Device, Vascular, For Promoting Embolization Cardiovascular Class 2 870.3300 2019-08-21
HCG Device, Neurovascular Embolization Neurology Class 2 882.5950 2019-08-21
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2021-01-26
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2021-01-26

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
3002807295 IONISOS SABLE-SUR-SARTHE, FR

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K984202 Howmedica, Inc. HOWMEDICA HUMERAL INTERCALARY SYSTEM 1999-02-05
K061824 Tornier TORNIER CEMENT RESTRICTOR 2006-09-14
K141345 Tornier S.A.S. AEQUALIS FX2 2014-11-18
K161478 Xenco Medical, LLC Xenco Medical Posterior Cervical System 2016-09-06
K963639 Acromed Corp. ACROMED PEDICLE SCREW 1996-11-14

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0026-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S
Z-0027-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector Medium 43-51mm, non-sterile, 1302-55M
Z-0028-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector Long 50-65mm, non-sterile, 1302-55L
Z-0029-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector X-Long 60-75mm, non-sterile, 1302-55XL
Z-0030-2011 Zimmer Inc. 2
SpeedLink 6.0 Transverse Connector Short 39.5-44mm, non-sterile, 1304-60S

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010178296. Last updated year: 2026. Please use registration number 3010178296 when referencing this establishment in official correspondence.
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