FDA Registration
Active
🇫🇷 France
PASS LP SPINAL SYSTEM
Reg #: 1000432246
·
FEI: 1000432246
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- MEDICREA INTERNATIONAL
- Registration Number
- 1000432246
- FEI Number
- 1000432246
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5389 route de Strasbourg - Vancia
- City
- RILLIEUX-LA-PAPE Auvergne-Rhone-Alpes
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K140738
Owner / Operator
- Firm Name
- Medtronic, Inc.
- Operator Number
- 2112641
- Address
- 710 Medtronic Parkway
- City
- Minneapolis
- State
- MN
- Postal Code
- 55432
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2021-10-20 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2021-10-20 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2021-10-20 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2021-10-20 |
Proprietary Names
PASS LP SPINAL SYSTEM
Establishment Types
Manufacture Medical Device