FDA Registration
Active
🇺🇸 United States
ATLAS SPINE INC.
Reg #: 3003855635
·
FEI: 3003855635
·
Expires 2026
Products
8
Proprietary Names
8
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- ATLAS SPINE INC.
- Registration Number
- 3003855635
- FEI Number
- 3003855635
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1555 Jupiter Park Dr Ste 1
- City
- JUPITER
- State
- FL
- ZIP
- 33458
- Country
- US
Regulatory Submissions
- 510(k) Number
- K050588
Owner / Operator
- Firm Name
- ATLAS SPINE INC.
- Operator Number
- 9053705
- Address
- 1555 JUPITER PARK DR., STE. 1, --
- City
- Jupiter
- State
- FL
- Postal Code
- 33458
- Country
- US
- Correspondent
- Matt Baynham
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2005-10-17 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2007-11-08 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2007-11-08 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2007-11-08 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2006-11-16 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2002-11-05 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2020-09-16 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2018-12-19 |
Proprietary Names
Verteview Plate System
Apelo Pedicle Screw System
Stature
Orthopedic Manual Surgical Instrument
HiJAK Cervical Stand Alone
V3 Plate System
HiJAK Cervical
Rebar PEEK
Establishment Types
Manufacture Medical Device