FDA Registration
Active
🇫🇷 France
Safe Medical
Reg #: 3013548554
·
FEI: 3013548554
·
Expires 2026
Products
8
Proprietary Names
17
Establishment Types
1
Classifications
8
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Registration Details
- Registration Name
- Safe Medical
- Registration Number
- 3013548554
- FEI Number
- 3013548554
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Zone Dactivite De Montepy, 80 Rue De Montepy
- City
- Fleurieux-Sur-L'Arbresle Rhone
- Country
- FR
Owner / Operator
- Firm Name
- Safe Medical
- Operator Number
- 10054418
- Address
- 80 Rue De Montepy, ZA De Montepy
- City
- Fleurieux s/ l'Arbresle
- State
- Rhone
- Postal Code
- 69210
- Country
- FR
- Correspondent
- Florence Lauck
US Agent
- Business Name
- XCIX DESIGN
- Contact Name
- Kyle Atwood
- Address
- 11 W. 8900 S.
- City
- Paradise
- State
- UT
- ZIP
- 84328
- Country
- US
- [email protected]
- Phone
- 435 5126808
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2023-11-21 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2023-11-21 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2023-11-21 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2023-11-21 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2021-09-16 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2024-04-03 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2025-03-11 |
| System, Facet Screw Spinal Device | MRW | Class U | Unknown | No | 2025-03-11 |
Proprietary Names
SPINEVISION LUMIS CANNULATED POLYAXIAL PEDICLE SCREW FIXATION SYSTEM
PLIF LITE AND TLIF LITE
Twin Peaks Lumbar Interbody Fusion System
VARILIFT-L INTERBODY FUSION DEVICE
Met One Czar Anterior Plate System
Xultan 5.5 Pedicle Screw System
PRIMALOK-SP INTERSPINOUS FUSION SYSTEM
SPINEVISION LUMIS CANNULATED PEDICLE SCREW FIXATION SYSTEM, SPINEVISION
Blue Mountain Cervical Plate System
VariLift-C
SINTEA Dual-lead multiaxial cannulated fenestrated screw
VariLift-LX Interbody Fusion System
VariLift-C Interbody Fusion System
Ayers Rock Cervical interbody fusion system
PRIMALOK-FF FACET FIXATION SYSTEM
VariLift-L Interbody Fusion Device
PLUS PIVOT LINK UNIVERSAL SYSTEM
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)