FDA Registration
Active
🇩🇪 Germany
MESA® Small Stature Spinal System
Reg #: 3004638532
·
FEI: 3004638532
·
Expires 2025
Products
5
Proprietary Names
1
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- PURACON GMBH
- Registration Number
- 3004638532
- FEI Number
- 3004638532
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Isarstrasse 1
- City
- Rosenheim Bavaria
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K133944
Owner / Operator
- Firm Name
- puracon GmbH
- Operator Number
- 10028435
- Address
- Isarstrasse 1
- City
- Rosenheim
- State
- Bavaria
- Postal Code
- D-83026
- Country
- DE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2023-03-21 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2023-03-21 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2023-03-21 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2023-03-21 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2023-03-21 |
Proprietary Names
MESA® Small Stature Spinal System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)