FDA Registration
Active
🇫🇷 France
Cousin Biotech
Reg #: 9616062
·
FEI: 3003258310
·
Expires 2026
Products
11
Proprietary Names
9
Establishment Types
2
Classifications
11
Registration Details
- Registration Name
- Cousin Biotech
- Registration Number
- 9616062
- FEI Number
- 3003258310
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- ALLEE DES ROSES
- City
- WERVICQ-SUD Nord
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K181799
Owner / Operator
- Firm Name
- Cousin Surgery
- Operator Number
- 9043669
- Address
- Allee des roses
- City
- Wervicq-Sud
- State
- Nord
- Postal Code
- 59117
- Country
- FR
- Correspondent
- FRANCK - PELLETIER
US Agent
- Business Name
- ProMedic, LLC
- Contact Name
- Matt Dryden
- Address
- 131 Bay Point Dr NE
- City
- Saint Petersburg
- State
- FL
- ZIP
- 33704
- Country
- US
- [email protected]
- Phone
- 239 3076063
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bone Fixation Cerclage, Sublaminar | OWI | Class 2 | Orthopedic | No | 2022-06-24 |
| Mesh, Surgical, Polymeric | FTL | Class 2 | General, Plastic Surgery | No | 2010-12-03 |
| Mesh, Surgical, Deployment Balloon | OQL | Class 2 | General, Plastic Surgery | No | 2010-12-03 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2007-12-03 |
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | Class 2 | General, Plastic Surgery | No | 2013-01-09 |
| Cerclage, Fixation | JDQ | Class 2 | Orthopedic | No | 2013-01-09 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2016-12-13 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2016-12-13 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2016-12-13 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2016-12-13 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2016-12-13 |
Proprietary Names
ResCUBE Ligament Fixation System
Bandloc Sterile Implant
Bandloc Duo Sterile Implant
CABSAIR® COMPOSITE
CABSAIR®
NuVasive® VersaTie System
4DDOME® (Trial Implant)
4DDOME®
Invictus Bands System
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)