FDA Registration
Active
🇫🇷 France
SIMON SAS
Reg #: 3010370880
·
FEI: 3010370880
·
Expires 2026
Products
22
Proprietary Names
6
Establishment Types
1
Classifications
22
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Registration Details
- Registration Name
- SIMON SAS
- Registration Number
- 3010370880
- FEI Number
- 3010370880
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 5 Rue Francois Guerin
- City
- Bayeux Calvados
- Country
- FR
Owner / Operator
- Firm Name
- SIMON SAS
- Operator Number
- 10043589
- Address
- Route d'Arganchy
- City
- Subles
- State
- Calvados
- Postal Code
- 14400
- Country
- FR
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2013-03-01 |
| Bone Fixation Cerclage, Sublaminar | OWI | Class 2 | Orthopedic | No | 2015-12-31 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2019-02-01 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2019-02-01 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2019-02-01 |
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 2016-01-19 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2020-01-02 |
| Shoulder Prosthesis, Reverse Configuration | PHX | Class 2 | Orthopedic | No | 2017-12-18 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | Class 2 | Orthopedic | No | 2017-12-18 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2018-07-20 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2013-03-01 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2019-02-01 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | Class 2 | Orthopedic | No | 2020-01-02 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 2018-07-20 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2018-07-20 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2019-02-01 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2023-12-28 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2023-12-28 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2019-02-01 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2019-02-01 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2017-12-18 |
| Probe | HXB | Class 1 | Orthopedic | No | 2018-07-20 |
Proprietary Names
Final Impactor
Intervertebral Fusion Device with Bone Graft, Lumbar
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Bone Fixation Cerclage, Sublaminar
TRIWAY® Tibiotalocalcaneal (TTC) arthoresis System
Appliance, Fixation, Spinal Intervertebral Body
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)