FDA Registration
Active
🇺🇸 United States
EMPIRICAL SPINE, INC.
Reg #: 3013114075
·
FEI: 3013114075
·
Expires 2026
Products
1
Proprietary Names
8
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- EMPIRICAL SPINE, INC.
- Registration Number
- 3013114075
- FEI Number
- 3013114075
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 18655 Madrone Pkwy Ste 180
- City
- Morgan Hill
- State
- CA
- ZIP
- 95037
- Country
- US
Regulatory Submissions
- PMA Number
- P220031
Owner / Operator
- Firm Name
- Empirical Spine, Inc.
- Operator Number
- 10095318
- Address
- 18655 Madrone Pkwy., Suite 180
- City
- Morgan Hill
- State
- CA
- Postal Code
- 95037
- Country
- US
- Correspondent
- Louie Fielding
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Spinous Process Tension Band Implant | SGK | Class 3 | Unknown | No | 2026-02-25 |
Proprietary Names
Limiflex Dynamic Sagittal Tether Symbol Plate
Limiflex Dynamic Sagittal Tether Instrument Tray
Limiflex Dynamic Sagittal Tether Holder
Limiflex Dynamic Sagittal Tether Tensioner
Limiflex Dynamic Sagittal Tether Passer
Limiflex Dynamic Sagittal Tether
Limiflex Dynamic Sagittal Tether Driver
Limiflex Dynamic Sagittal Tether Tensioner Clip
Establishment Types
Manufacture Medical Device