FDA Registration
Active
🇺🇸 United States
Astura Medical
Reg #: 3015941638
·
FEI: 3011764740
·
Expires 2025
Products
4
Proprietary Names
0
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- Astura Medical
- Registration Number
- 3015941638
- FEI Number
- 3011764740
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 4949 W Royal Ln
- City
- Irving
- State
- TX
- ZIP
- 75063
- Country
- US
Regulatory Submissions
- 510(k) Number
- K231694
Owner / Operator
- Firm Name
- Astura Medical
- Operator Number
- 10051052
- Address
- 4949 W Royal Ln.
- City
- Irving
- State
- TX
- Postal Code
- 75063
- Country
- US
- Correspondent
- Thomas Purcell
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2023-12-20 |
| Bone Fixation Cerclage, Sublaminar | OWI | Class 2 | Orthopedic | No | 2023-12-20 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2023-12-20 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2023-12-20 |
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198