FDA Registration
Active
🇺🇸 United States
Astura Medical
Reg #: 3015941638
·
FEI: 3011764740
·
Expires 2026
Products
19
Proprietary Names
5
Establishment Types
3
Classifications
19
Registration Details
- Registration Name
- Astura Medical
- Registration Number
- 3015941638
- FEI Number
- 3011764740
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 4949 W Royal Ln
- City
- Irving
- State
- TX
- ZIP
- 75063
- Country
- US
Regulatory Submissions
- 510(k) Number
- K202495
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 |
|---|---|---|---|---|---|
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2021-02-11 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2024-10-21 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2021-07-29 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2021-07-29 |
| Bone Fixation Cerclage, Sublaminar | OWI | Class 2 | Orthopedic | No | 2023-12-20 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2016-04-08 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2016-04-08 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2016-04-08 |
| Spinal Vertebral Body Replacement Device - Cervical | PLR | Class 2 | Orthopedic | No | 2024-03-11 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2024-03-11 |
| Bone Cement, Posterior Screw Augmentation | PML | Class 2 | Orthopedic | No | 2026-01-30 |
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2023-11-15 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2018-02-07 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2020-10-26 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2016-05-13 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2025-11-24 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2020-10-26 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2016-01-29 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2020-10-26 |
Proprietary Names
HALF DOME PLIS
BRIDALVEIL Occipital Cervical Thoracic System
ALTA Cervical Interbody Spacer
OLYMPIC Deformity Band System
ZION Anterior Cervical Fixation System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device