FDA Registration
Active
🇺🇸 United States
Spike Driver (Final)
Reg #: 3015991317
·
FEI: 3015991317
·
Expires 2025
Products
1
Proprietary Names
20
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- ELEVATION SPINE
- Registration Number
- 3015991317
- FEI Number
- 3015991317
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2511 Garden Road, Suite B125
- City
- Monterey
- State
- CA
- ZIP
- 93940
- Country
- US
Owner / Operator
- Firm Name
- Elevation Spine
- Operator Number
- 10061171
- Address
- 2511 Garden Road, Suite B125
- City
- Monterey
- State
- CA
- Postal Code
- 93940
- Country
- US
- Correspondent
- Christine Scifert
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2022-12-14 |
Proprietary Names
Spike Driver (Final)
Guide, 7mm
Carriage 7mm
Assembly tool
Guide, 9mm
Guide, 5-6mm
Guide, 10mm
Spike Driver
Spike Removal Tool
Carriage 10mm
Spike Extractor
Locking Plate Inserter
Spike Driver, 8-9mm
Spike Driver, 5-7mm
Spike Driver, 10mm
Carriage 9mm
Carriage 5-6mm
Inserter
Guide, 8mm
Carriage 8mm
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility