FDA Registration
Active
🇺🇸 United States
BLUSTONE SYNERGY, LLC
Reg #: 3014019090
·
FEI: 3014019090
·
Expires 2026
Products
8
Proprietary Names
18
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- BLUSTONE SYNERGY, LLC
- Registration Number
- 3014019090
- FEI Number
- 3014019090
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 5520 Ventana Ct
- City
- Pueblo
- State
- CO
- ZIP
- 81005
- Country
- US
Regulatory Submissions
- 510(k) Number
- K172330
Owner / Operator
- Firm Name
- Blustone Synergy, LLC
- Operator Number
- 10055810
- Address
- 5520 Ventana Ct.
- City
- Pueblo
- State
- CO
- Postal Code
- 81005
- Country
- US
- Correspondent
- Tom Gentry
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2017-12-22 |
| Pusher, Socket | HXO | Class 1 | Orthopedic | No | 2017-12-22 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2017-12-21 |
| Template | HWT | Class 1 | Orthopedic | No | 2017-12-22 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2017-10-09 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2017-10-09 |
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 2017-12-22 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2017-12-22 |
Proprietary Names
Blustone Synergy Slate Parallel Cervical Rasp
Blustone Synergy Slate Lordotic Cervical Rasp
Blustone Synergy Baalt Lumbar PLIF Pusher
Blustone Synergy Obsidian Lumbar TLIF Pusher
Blustone Synergy Silica Corpectomy/Slate Cervical Pusher
Blustone Synergy Silica Corpectomy System
Blustone Synergy Slate Parallel Cervical Trial
Blustone Synergy Basalt/Obsidian/Magma Lumbar Trial/Spreader
Blustone Synergy Slate Lordotic Cervical Trial
Blustone Synergy Obsidian Lumbar Interbody Fusion System
Blustone Synergy Basalt Lumbar Interbody Fusion System
Blustone Synergy Magma Lumbar Interbody Fusion System
Blustone Synergy Slate Cervical Interbody Fusion System
Blustone Synergy Basalt/Magma/Obsidian Lumbar Shaver
Blustone Synergy Silica Corpectomy/Slate Cervical Inserter
Blustone Synergy Magma Lumbar Lateral Inserter
Blustone Synergy Obsidian Lumbar TLIF Inserter
Blustone Synergy Basalt Lumbar PLIF Inserter
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility