FDA Registration
Active
🇫🇷 France
SELENIUM MEDICAL S.A.S.
Reg #: 1000461041
·
FEI: 1000461041
·
Expires 2026
Products
23
Proprietary Names
28
Establishment Types
1
Classifications
23
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Registration Details
- Registration Name
- SELENIUM MEDICAL S.A.S.
- Registration Number
- 1000461041
- FEI Number
- 1000461041
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 9049 Rue de Quebec
- City
- La Rochelle Charente-Maritime
- Country
- FR
Owner / Operator
- Firm Name
- Selenium Medical S.A.S.
- Operator Number
- 10045214
- Address
- 9049 Rue de Quebec
- City
- La Rochelle
- State
- Charente-Maritime
- Postal Code
- 17000
- Country
- FR
US Agent
- Business Name
- DAWA MEDICAL LLC
- Contact Name
- Stephan TOUPIN
- Address
- 7320 NW, 12th street suite 103
- City
- Miami
- State
- FL
- ZIP
- 33126
- Country
- US
- [email protected]
- Phone
- 786 7311159
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2019-07-22 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2018-01-09 |
| Bone Cement | LOD | Class 2 | Orthopedic | No | 2026-02-11 |
| Cement, Bone, Vertebroplasty | NDN | Class 2 | Orthopedic | No | 2026-02-11 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2021-09-15 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2021-09-15 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2025-04-09 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2018-01-09 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2018-01-09 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2018-01-09 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2018-05-28 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2020-04-27 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2020-04-27 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2018-04-12 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2018-04-12 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2018-01-09 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2018-04-12 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2018-04-12 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2018-04-12 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2018-04-12 |
| Bit, Surgical | GFG | Class 1 | General, Plastic Surgery | No | 2025-04-28 |
| Bur, Surgical, General & Plastic Surgery | GFF | Class 1 | General, Plastic Surgery | No | 2025-04-24 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2022-08-05 |
Proprietary Names
Xultan 5.5 Pedicle Screw System
Nexis
HYPREVENTION
KONTACT DENTAL IMPLANT SYSTEM
GoLIF! Lumbar Interbody Fusion System
Novastep
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
TOEGRIP
Czar Anterior Plate System
BITE Compression Screws
Hammer Toe Reaming Implant System (HTR); Trilliant K-Wire
In2Bones Fracture and Correction System
GoPLF! Posterior Lateral Fusion System
Percutaneous Burrs
Romero Cervical Cage
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)