FDA Registration
Active
🇨🇷 Costa Rica
CD HORIZON SOLERA SPINAL SYSTEM
Reg #: 3014725904
·
FEI: 3014725904
·
Expires 2025
Products
6
Proprietary Names
1
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- Medtronic Medical Costa Rica S.R.L.
- Registration Number
- 3014725904
- FEI Number
- 3014725904
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Coyol Free Zone Bldg B7, Multitenant 7-8, Module F
- City
- Coyol Alajuela
- Country
- CR
Regulatory Submissions
- 510(k) Number
- K132328
Owner / Operator
- Firm Name
- Medtronic, Inc.
- Operator Number
- 2112641
- Address
- 710 Medtronic Parkway
- City
- Minneapolis
- State
- MN
- Postal Code
- 55432
- Country
- US
US Agent
- Business Name
- MEDTRONIC INC.
- Contact Name
- Michelle Obenauer
- Address
- Medtronic Sofamor Danek Headquarters, 1800 Pyramid Place
- City
- Memphis
- State
- TN
- ZIP
- 38132
- Country
- US
- [email protected]
- Phone
- 901 3992117
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2014-03-26 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2014-03-26 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2014-03-26 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2014-03-26 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2014-03-26 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2014-03-26 |
Proprietary Names
CD HORIZON SOLERA SPINAL SYSTEM
Establishment Types
Manufacture Medical Device