FDA Registration
Active
🇺🇸 United States
AURORA SPINE, INC.
Reg #: 3010326971
·
FEI: 3010326971
·
Expires 2026
Products
10
Proprietary Names
18
Establishment Types
3
Classifications
10
Registration Details
- Registration Name
- AURORA SPINE, INC.
- Registration Number
- 3010326971
- FEI Number
- 3010326971
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 1930 Palomar Point Way, Suite #103
- City
- Carlsbad
- State
- CA
- ZIP
- 92008
- Country
- US
Regulatory Submissions
- 510(k) Number
- K071743
Owner / Operator
- Firm Name
- Aurora Spine
- Operator Number
- 10045511
- Address
- 1930 Palomar Point Way, Ste 103
- City
- Carlsbad
- State
- CA
- Postal Code
- 92008
- Country
- US
- Correspondent
- Laszlo Garamszegi
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2018-12-10 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2021-11-01 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2021-11-01 |
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2022-11-15 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2013-11-25 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2018-10-26 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2014-12-31 |
| Spinous Process Plate | PEK | Class 2 | Orthopedic | No | 2014-12-31 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2021-11-01 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2022-11-15 |
Proprietary Names
Surgical Trays
SiLO TFX MIS Sacroiliac Fusion System
DISCOVERY MIS Interbody Fusion System
ECHO XL MIS Interbody Fusion System
VOX MIS Interbody Fusion System
EOS MIS Interbody Fusion System
AFFINITY MIS Interbody Fusion System
ECHO MIS Interbody Fusion System
ZIP MIS Interspinous Fusion System
ZIP ULTRA MIS Interspinous Fusion System
ZIP LP MIS Interspinous Fusion System
ZIP 51 MIS Interspinous Fusion System
ZIP 51 ULTRA MIS Interspinous Fusion System
ZIP MIS Interlaminar Fusion System
SILO TFX
DEXA-C Cervical Interbody System
APOLLO Anterior Cervical Plate (ACP) System
DEXA SOLO-L Standalone Anterior Fusion System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device