Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1000461041

FEI Number

1000461041

Entity Name

SELENIUM MEDICAL S.A.S.

City/State/Country

La Rochelle Charente-Maritime, FR

Establishment Address

9049 Rue de Quebec, La Rochelle Charente-Maritime 17000, FR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Selenium Medical S.A.S. (Owner Number: 10045214)

Owner / Operator Contact Address

9049 Rue de Quebec, La Rochelle, FR-17 17000, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Xultan 5.5 Pedicle Screw System Nexis HYPREVENTION HYPREVENTION KONTACT DENTAL IMPLANT SYSTEM GoLIF! Lumbar Interbody Fusion System Nexis Novastep Nexis Lync Arcad Reduce Fracture Plating System View Plating System Virtu C Spinal Implant System SternaFuse Fixation System NuVasive® VuePoint® II OCT System Bony Trauma Extremity System (BTES) Screw Range - NX Nail System centrolock NuVasive® RELINE System Sniper Staple CoLink Plating System Arcad 2 Drill bits (reamer) Airlock centrolock

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2019-07-22
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2018-01-09
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2026-02-11
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2026-02-11
NDN	Cement, Bone, Vertebroplasty	Orthopedic	Class 2	888.3027	2026-02-11
LOD	Bone Cement	Orthopedic	Class 2	888.3027	2026-02-11
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2021-09-15
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2021-09-15
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2025-04-09
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2025-04-10
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2025-04-10
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2018-01-09
HWE	Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	General, Plastic Surgery	Class 1	878.4820	2018-01-09
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2025-01-27
HTY	Pin, Fixation, Smooth	Orthopedic	Class 2	888.3040	2018-01-09
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-01-09
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2018-05-28
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-05-28
MQP	Spinal Vertebral Body Replacement Device	Orthopedic	Class 2	888.3060	2020-04-27
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2020-04-27
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2022-08-05
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2022-08-05
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2018-04-12
NKG	Posterior Cervical Screw System	Orthopedic	Class 2	888.3075	2018-04-12
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-03-16
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2018-01-09
NKB	Thoracolumbosacral Pedicle Screw System	Orthopedic	Class 2	888.3070	2018-04-12
MNI	Orthosis, Spinal Pedicle Fixation	Orthopedic	Class 2	888.3070	2018-04-12
MNH	Orthosis, Spondylolisthesis Spinal Fixation	Orthopedic	Class 2	888.3070	2018-04-12
OSH	Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis	Orthopedic	Class 2	888.3070	2018-04-12
KWQ	Appliance, Fixation, Spinal Intervertebral Body	Orthopedic	Class 2	888.3060	2018-04-12
KWP	Appliance, Fixation, Spinal Interlaminal	Orthopedic	Class 2	888.3050	2018-04-12
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-05-28
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-05-28
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2018-05-28
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2025-01-27
GFG	Bit, Surgical	General, Plastic Surgery	Class 1	878.4820	2025-04-28
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2018-01-09
HRS	Plate, Fixation, Bone	Orthopedic	Class 2	888.3030	2020-01-08

Official Correspondent

No official correspondent registered.

US Agent Details

Stephan TOUPIN Business: DAWA MEDICAL LLC Email: stoupin@dawamedical.com Phone: (786) 7311159

Related Public Records

Same Entity

Selenium Medical S.A.S.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K163363	Surgtech, Inc.	SurgTech Thoracolumbosacral (TLS) Posterior Fixation System	2017-04-05
K252461	Spinal Resources, Inc.	Swedge Pedicle Screw Fixation System Bezier Rod	2026-01-13
K140696	Pioneer Surgical Technology, Inc.	STREAMLINE TL SPINAL FIXATION SYSTEM	2014-04-10
K141398	Medicrea International SA	PASS LP SPINAL SYSTEM	2015-01-09
K160980	Spineology, Inc.	Threshold Pedicular Fixation System, Palisade Pedicular Fixation System	2016-05-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2013	Synthes USA HQ, Inc.	2	MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).
Z-0004-2008	Abbott Spine	2	PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.
Z-0005-2008	Abbott Spine	2	PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60.
Z-0020-06	Pioneer Surgical Technology	2	Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 45 mm; Catalog number 10-575-PA-45.
Z-0021-06	Pioneer Surgical Technology	2	Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 40 mm; Catalog number 10-575-PA-40.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1000461041. Last updated year: 2026. Please use registration number 1000461041 when referencing this establishment in official correspondence.