FDA Registration
Active
🇺🇸 United States
Unified Spine, LLC
Reg #: 3006215390
·
FEI: 3006215390
·
Expires 2026
Products
16
Proprietary Names
6
Establishment Types
2
Classifications
16
Registration Details
- Registration Name
- Unified Spine, LLC
- Registration Number
- 3006215390
- FEI Number
- 3006215390
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 6295 Maxtown Road, Suite #500
- City
- Westerville
- State
- OH
- ZIP
- 43082
- Country
- US
Regulatory Submissions
- 510(k) Number
- K123487
Owner / Operator
- Firm Name
- Unified Spine, LLC
- Operator Number
- 10083837
- Address
- 6295 Maxtown Road, Suite #500
- City
- Westerville
- State
- OH
- Postal Code
- 43082
- Country
- US
- Correspondent
- Scott Smith
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Awl | HWJ | Class 1 | Orthopedic | No | 2021-12-22 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2021-12-22 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2021-12-22 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2021-12-22 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2021-12-22 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2021-12-22 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2021-12-22 |
| Instrument, Bending Or Contouring | HXP | Class 1 | Orthopedic | No | 2021-12-22 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2021-12-22 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2021-12-22 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2021-12-22 |
| Caliper | KTZ | Class 1 | Orthopedic | No | 2021-12-22 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2021-12-22 |
| Probe | HXB | Class 1 | Orthopedic | No | 2021-12-22 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2021-12-22 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2021-12-22 |
Proprietary Names
GSO GS1 Cannulated Screw System
GSO ACP1 Anterior Cervical Plate System
Gso Gs1 Spacer
Gso GS1 Spinal System
GSO PCT Spinal System
Gso Bone Fixation Fasteners
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device