Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010162973

FEI Number

3002807041

Entity Name

Synergy Health Marseille SAS

City/State/Country

MARSEILLE CEDEX 14 Provence-Alpes-Cote d'Azur, FR

Establishment Address

MIN 712 - LES Arnavaux, MARSEILLE CEDEX 14 Provence-Alpes-Cote d'Azur 13323, FR

Establishment Type(s)

Sterilize Medical Device for Another Party (Contract Sterilizer)

Owner / Operator

STERIS Corporation (Owner Number: 10042227)

Owner / Operator Contact Address

5960 Heisley Road, Mentor, OH 44060, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

DTMedtech10904 (MS) - Hintermann Series H3 Total Ankle Replacement System BBraun11480 (MS) - B. Braun Surgical, S.A. (Dagrofil) Newclip11561 (MS) -Clavicle Plate screwdriver; Clavicle prehensor screwdriver countersink; Distal Radius Plate screwdriv Newclip11561 (MS) - ACTIV Ankle RemovalkitACTIV Ankle screwdriver; Alians Fragment Specific screwdriver; Alians screwdri Newclip11561 (MS) - Distal Radius removal kit; Elbow screwdriver; Foot & Hand Motion screwdriver; Footmotion screwdrive Newclip11561 (MS) - HTO hexagonal screwdriver; Large screw screwdriver; Newclip Radius screwdriver; Newclip Shoulder FCI11517 (MS) - Enucleation/evisceration implants Newclip11561 (MS) - Distal Radius Plating System Newclip11561 (MS) - Large Screw System Newclip11561 (MS) - FTP DTMedtech10904 (MS) - Hintermann Series H2 Total Ankle System Newclip11561 (MS) - Humerus Locking Plating System Newclip11561 (MS) - Footmotion Plating System Newclip11561 (MS) - Radius instrumentation set; Ulnar Instrumentation set Newclip11561 (MS) - ACTIV Ankle instrumentation set; ACTIV HTO instrumentation set; Activ instrumentation set Base; Acti DORC10527 (VL1) - Tray, Surgical, Instrument Newclip11561 (MS) - Stainless steel - Cover; HammerToe instrumentation set - Base; HammerToe instrumentation set Newclip11561 (MS) - Clavicle Distal instrumentation set; Elbow instrumentation set; Foot and Hand Motion Newclip11561 (MS) - Footmotion instrumentation set; Footmotion Plating System MTP instrumentation set; HammerToe Newclip11561 (MS) - Screws tray; Activ instrumentation set Top Alians Elbow Distal Humerus Y Plates instrumentation set Newclip11561 (MS) - HammerToe instrumentation set Stainless steel - Base; Humerus instrumentation set; Large screw Newclip11561 (MS) - Length gauge for pin L120 mm / template for extremity screws - STERILE Newclip11561 (MS) - Length gauge for pin 1.2 mm - L75 mm - STERILE Newclip11561 (MS) - Activ Fuse FCI11517 (MS) - Ocular Shield FCI11517 (MS) - SILICONE CONFORMER FCI11517 (MS) - SYMBLEPHARON RINGS, 25MM LARGE FCI11517 (MS) - PERFORATED CONFORMERS, 26MM LARGE FCI11517 (MS) - SYMBLEPHARON RINGS, 20MM SMALL FCI11517 (MS) - PERFORATED CONFORMERS, 23MM MEDIUM FCI11517 (MS) - SYMBLEPHARON RINGS, 22MM MEDIUM FCI11517 (MS) - PERFORATED CONFORMERS, 20MM SMALL Noraker11562 (MS) - GlassBone Granules FCI11517 (MS) - LACRIMAL DILATOR DISPOSABLE Newclip11561 (MS) - BIT, DRILL Newclip11561 (MS) - Alians Fragment Specific FCI11517 (MS) - Ptosis Sling Noraker11562 (MS) - ARTHREX QUICKSET; ARTHREX QUICKSET KIT; GRAFTYS QUICKSET; GRAFTYS QUICKSET KIT Newclip11561 (MS) - Alians Elbow Plating System Newclip11561 (MS) - KEMIS H,3 Knife Newclip11561 (MS) - DTO S Newclip11561 (MS) - Activmotion S Keri12785 (MS) - TOUCH CMC 1 Prosthesis Teknimed11593 (MS) - Ceraform DilonTech17949 (MS) - Hemoblast Bellows Newclip11561 (MS) - Large Screw System FCI11517 (MS) - Lacrijet Newclip11561 (MS) - SCREW, FIXATION, BONE Newclip11561 (MS) - Activ Ankle Locking Plate System Newclip11561 (MS) - Alians Elbow Locking Plating System Newclip11561 (MS) - Soft tissues protector BBraun11480 (MS) - B. Braun Surgical, S.A. (Steelex) FCI11517 (MS) - Retinal Strip FCI11517 (MS) - Retinal Sleeve FCI11517 (MS) - Retinal Band FCI11517 (MS) - Retinal Sponge Newclip11561 (MS) - Alians Clavicle range Teknimed11593 (MS) - Osteofast Dental BBraun11480 (MS) - B. Braun Surgical, S.A. (Silkam) Newclip11561 (MS) - ACTIV Ankle countersink; Alians elbow countersink; Alians ulnar countersinkClaviclePlatecountersink; Newclip11561 (MS) - Humerus reamer w/ quick coupling system; Large screw countersink; Large screw reamer tip Newclip11561 (MS) - Foot & Hand Motion countersink; Foot & Hand Motion pre-tapering reamer; Newclip11561 (MS) - HammerToe convex / concave reamers; HammerToe punch; HammerToe reamer; HTO countersink FCI11517 (MS) - PVP perforated plug BBraun11480 (MS) - B. Braun Surgical, S.A. (Dafilon)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OWI	Bone Fixation Cerclage, Sublaminar	Orthopedic	Class 2	888.3010	2020-01-02
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-03-07
EHZ	Evacuator, Oral Cavity	Dental	Class 1	872.6640	2019-02-20
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2017-01-09
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2015-11-03
NTG	Prosthesis, Ankle, Uncemented, Non-Constrained	Unknown	Class 3	N/A	2023-05-23
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-05-22
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2017-01-19
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2025-02-26
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-03-07
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2013-01-15
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2023-11-13
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2019-12-19
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-11-17
HPZ	Implant, Eye Sphere	Ophthalmic	Class 2	886.3320	2025-11-24
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-03-07
JWH	Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	Orthopedic	Class 2	888.3560	2026-06-11
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2013-02-01
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	Cardiovascular	Class 2	870.3470	2019-03-04
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2019-02-20
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2023-03-08
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2019-03-07
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-06-17
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-06-17
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2023-11-13
MAL	Graft, Vascular, Synthetic/Biologic Composite	Cardiovascular	Class 2	870.3450	2019-03-04
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2024-05-22
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	Class 2	892.1650	2025-11-21
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	Class 2	892.1650	2025-11-21
OWB	Interventional Fluoroscopic X-Ray System	Radiology	Class 2	892.1650	2025-11-21
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-03-07
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-03-07
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2023-03-08
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-03-07
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-03-07
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2017-01-19
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2017-01-19
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2017-01-19
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2017-01-19
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-06-17
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-06-19
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-06-19
HSN	Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer	Orthopedic	Class 2	888.3110	2023-05-23
JEY	Plate, Bone	Dental	Class 2	872.4760	2013-01-08
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2020-01-02
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-06-17
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-06-17
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-05-22
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2024-02-29
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-06-19
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-06-19
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-03-07
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2026-03-19
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-03-07
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-03-07
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-11-26
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2024-05-22
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2019-02-23
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2025-06-17
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2018-11-13
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2024-03-18
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-06-19
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-06-19
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-12-15
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-03-07
OWI	Bone Fixation Cerclage, Sublaminar	Orthopedic	Class 2	888.3010	2019-12-19
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-03-07
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2015-11-03
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-03-07
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2014-04-28
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2015-11-03
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2024-05-22
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-03-07
HQN	Conformer, Ophthalmic	Ophthalmic	Class 2	886.3130	2025-11-24
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-05-22
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2013-02-01
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2026-01-05
HNW	Dilator, Lachrymal	Ophthalmic	Class 1	886.4350	2019-11-11
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-03-07
HTW	Bit, Drill	Orthopedic	Class 1	888.4540	2013-01-15
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-06-19
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-06-19
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-02-01
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2013-02-01
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-02-01
EBW	Controller, Foot, Handpiece And Cord	Dental	Class 1	872.4200	2020-01-06
HJZ	Crutch, Ptosis	Ophthalmic	Class 1	886.5600	2025-11-24
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2023-11-13
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2015-11-03
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2023-11-13
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2015-11-03
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2015-11-03
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-06-19
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-06-19
GDZ	Handle, Scalpel	General, Plastic Surgery	Class 1	878.4800	2018-06-18
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-06-19
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-06-19
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2015-11-03
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-06-19
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-06-19
SFA	Prosthesis, Finger, Semi-Constrained, Metal/Polymer	Unknown	Class 3	N/A	2026-05-28
MQV	Filler, Bone Void, Calcium Compound	Orthopedic	Class 2	888.3045	2024-02-29
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2025-07-30
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2019-03-07
PMX	Absorbable Collagen Hemostatic Agent With Thrombin	General, Plastic Surgery	Class 3	878.4490	2026-05-28
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-06-19
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2014-04-28
OVE	Intervertebral Fusion Device With Integrated Fixation, Cervical	Orthopedic	Class 2	888.3080	2023-11-13
OWI	Bone Fixation Cerclage, Sublaminar	Orthopedic	Class 2	888.3010	2020-01-02
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2019-03-07
OKS	Lacrimal Stents And Intubation Sets	Unknown	Class U	N/A	2025-11-24
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2019-03-07
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2023-11-13
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2023-11-13
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-06-19
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-06-19
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2024-05-22
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-06-17
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-06-17
MRW	System, Facet Screw Spinal Device	Unknown	Class U	N/A	2026-04-07
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2019-12-20
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2019-12-20
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2019-12-20
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2019-12-20
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2023-06-08
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2024-05-22
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2023-07-18
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2015-11-03
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-06-17
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-06-17
MAL	Graft, Vascular, Synthetic/Biologic Composite	Cardiovascular	Class 2	870.3450	2019-03-04
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-03-07
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-03-07
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2016-11-12
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2017-01-19
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2017-01-19
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2017-01-19
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2017-01-19
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2022-02-17
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2022-02-17
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2022-02-17
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-03-07
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2015-11-03
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2015-11-03
DZM	Needle, Dental	Dental	Class 1	872.4730	2015-08-06
GAQ	Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile	General, Plastic Surgery	Class 2	878.4495	2025-02-26
OWI	Bone Fixation Cerclage, Sublaminar	Orthopedic	Class 2	888.3010	2022-10-25
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2022-10-25
DSY	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter	Cardiovascular	Class 2	870.3450	2013-02-07
JEY	Plate, Bone	Dental	Class 2	872.4760	2012-11-16
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2013-02-05
HQX	Implant, Orbital, Extra-Ocular	Ophthalmic	Class 2	886.3340	2025-11-24
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2023-11-17
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2023-11-17
OWI	Bone Fixation Cerclage, Sublaminar	Orthopedic	Class 2	888.3010	2019-12-20
DSY	Prosthesis, Vascular Graft, Of 6mm And Greater Diameter	Cardiovascular	Class 2	870.3450	2013-02-07
OWI	Bone Fixation Cerclage, Sublaminar	Orthopedic	Class 2	888.3010	2017-01-09
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2015-11-03
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2024-05-22
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2019-03-07
LXT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite	Orthopedic	Class 2	888.3030	2019-03-07
MAL	Graft, Vascular, Synthetic/Biologic Composite	Cardiovascular	Class 2	870.3450	2019-03-04
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-06-19
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-06-19
LYC	Bone Grafting Material, Synthetic	Dental	Class 2	872.3930	2024-02-29
OLO	Orthopedic Stereotaxic Instrument	Neurology	Class 2	882.4560	2026-04-20
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2017-01-19
MAI	Fastener, Fixation, Biodegradable, Soft Tissue	Orthopedic	Class 2	888.3030	2024-05-22
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2023-11-13
OVD	Intervertebral Fusion Device With Integrated Fixation, Lumbar	Orthopedic	Class 2	888.3080	2023-11-13
GAP	Suture, Nonabsorbable, Silk	General, Plastic Surgery	Class 2	878.5030	2025-02-26
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2024-05-22
HTO	Reamer	Orthopedic	Class 1	888.4540	2016-11-12
LZU	Plug, Punctum	Unknown	Class U	N/A	2025-11-24
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2013-02-01
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2013-02-01
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2013-02-01
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2013-02-01
DXZ	Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene	Cardiovascular	Class 2	870.3470	2019-03-04
GAR	Suture, Nonabsorbable, Synthetic, Polyamide	General, Plastic Surgery	Class 2	878.5020	2025-02-26

Official Correspondent

No official correspondent registered.

US Agent Details

Becky Aldhizer Business: Synergy Health Email: Becky_Aldhizer@steris.com Phone: (440) 4687462

Related Public Records

Same Entity

STERIS Corporation

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3018811167	MEDIVATORS INC	Rogers, MN, US
3038285067	Synergy Sterilisation Kulim (M) Sdn. Bhd	Seberang Perai Selatan Pulau Pinang, MY
3031571464	Herotron E-Beam Service GmbH	Bitterfeld Saxony-Anhalt, DE
3010897183	Synergy Health Marseille SAS	CHUSCLAN Gard, FR
3008252486	ELECTRON BEAM SDN BHD	Port Klang Selangor, MY

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K042598	Zimmer, Inc.	PERIARTICULAR LOCKING PLATES AND SCREWS, 2357 AND 2359 SERIES	2004-10-29
K190842	Jiangsu Trauhui Medical Instrument Co., Ltd.	Comus Locking Plate systems	2020-02-03
K130510	Arthrex, Inc.	ARTHREX COMPRESSION PLATES	2013-09-25
K202803	Newclip Technics	Activmotion S DTO	2021-12-16
K081806	Idi Biomedical, LLC	IDI IMPLANT SYSTEM	2008-11-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0034-2022	Flower Orthopedics Corporation	2	Flower E-Kit, Advanced-Bone Fixation Fasterner-Fixation of Ref: EWK 201
Z-0010-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Z-0017-2026	S.I.N. Implant System Ltda Rua Soldador Ocimar Guimaraes da Silva 421 Jardim Analia Franco Sao Paulo Brazil	2	IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF: ILM 3513N; IMPLANT EPIKUT PLUS MT16 3,5X15,0MM, REF: ILM 3515N; IMPLANT EPIKUT PLUS MT16 3,8X10,0MM, REF: ILM 3810N; IMPLANT CM16 3,8 X 11MM, REF: ILM 3811N; IMPLANT EPIKUT PLUS MT16 3,8X15,0MM, REF: ILM 3815N; IMPLANT EPIKUT PLUS MT16 4,0X10,0MM, REF: ILM 4010N; IMPLANT EPIKUT PLUS MT16 4,0X11,5MM, REF: ILM 4011N; IMPLANT EPIKUT PLUS MT16 4,0X13,0MM, REF: ILM 4013N; IMP EPIKUT PLUS LONG MT16 4,0X20,0MM, RES: ILM 4020N; IMPLANT EPIKUT PLUS MT16 4,0X8,5MM, RES: ILM 4085N; IMPLANT EPIKUT PLUS MT16 4,5X13,0MM, REF: ILM 4513N; IMPLANT EPIKUT PLUS MT16 4,5X15,0MM, REF: ILM 4515N; IMPLANT EPIKUT PLUS MT16 4,5X8,5MM, REF: ILM 4585N; IMPLANT EPIKUT PLUS MT16 5,0X10,0MM, REF: ILM 5010N; IMPLANT EPIKUT PLUS MT16 5,0X11,5MM, REF: ILM 5011N; IMPLANT EPIKUT PLUS MT16 4,5X10,0MM, REF: ILM 4510N; IMPLANT EPIKUT PLUS MT16 5,0X13,0MM, RES: ILM 5013N; IMPLANT EPIKUT PLUS MT16 5,0X15,0MM, REF: ILM 5015N; IMPLANT EPIKUT PLUS MT16 5,0X8,5MM, REF: ILM 5085N; IMP EPIKUT PLUS LONG MT16 4,0X18,0MM, REF: ILM 4018N; IMP EPIKUT PLUS LONG MT16 3,8X18,0MM, REF: ILM 3818N; IMPLANT EPIKUT PLUS MT16 4,5X11,5MM, REF: ILM 4511N; IMPLANT EPIKUT MT16 4,5X15,0MM, REF: ILM 4515; IMPLANT EPIKUT MT16 4,5X8,5MM, REF: ILM 4585; IMPLANT EPIKUT MT16 3,8X13,0MM, REF: ILM 3813; IMPLANT EPIKUT MT16 3,8X15,0MM, REF: ILM 3815; IMPLANT EPIKUT MT16 5,0X8,5MM, REF: ILM 5085; IMPLANT EPIKUT MT16 3,8X11,5MM, REF: ILM 3811; IMPLANT EPIKUT PLUS MT16 3,8X20,0MM, REF: ILM 3820N; IMPLANT EPIKUT PLUS MT16 4,5X18,0MM, REF: ILM 4518N; IMPLANT UNITITE MORSE COMPACT 6.0X7MM, REF: UCMC 6007N
Z-0018-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing LLC s dental implant product line consists of one-piece and two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Z-0019-2020	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	2	Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010162973. Last updated year: 2026. Please use registration number 3010162973 when referencing this establishment in official correspondence.