FDA Registration
Active
🇫🇷 France
SPINEGUARD, SA
Reg #: 3008102049
·
FEI: 3008102049
·
Expires 2026
Products
8
Proprietary Names
27
Establishment Types
2
Classifications
8
Registration Details
- Registration Name
- SPINEGUARD, SA
- Registration Number
- 3008102049
- FEI Number
- 3008102049
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 10, Cours Louis Lumiere
- City
- Vincennes Paris
- Country
- FR
Regulatory Submissions
- 510(k) Number
- K152747
Owner / Operator
- Firm Name
- SpineGuard, SA
- Operator Number
- 10031002
- Address
- 10, cours Louis LUMIERE
- City
- Vincennes
- State
- Paris
- Postal Code
- 94300
- Country
- FR
- Correspondent
- Stephane Bette
US Agent
- Business Name
- SPINEGUARD
- Contact Name
- Stephane Bette
- Address
- 1434 Spruce St
- City
- Boulder
- State
- CO
- ZIP
- 80302
- Country
- US
- [email protected]
- Phone
- 720 7268085
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2009-12-31 |
| Stimulator, Nerve | ETN | Class 2 | Ear, Nose, Throat | No | 2016-06-15 |
| Neurosurgical Nerve Locator | PDQ | Class 2 | Ear, Nose, Throat | No | 2016-06-15 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2013-01-18 |
| Stylet, Surgical, General & Plastic Surgery | GAH | Class 1 | General, Plastic Surgery | No | 2016-12-22 |
| Sacroiliac Joint Guidewire Placement Device | SCY | Class 2 | Orthopedic | No | 2025-01-20 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2010-04-08 |
| Drills, Burrs, Trephines & Accessories (Manual) | HBG | Class 2 | Neurology | No | 2017-01-18 |
Proprietary Names
PediGuard DSG Plastic Sleeve
SpineGuard PediGuard Threaded
PediGuard 120mm Trocar Needle
Cannulated PediGuard Cannula 120mm
PediGuard Stiffer Cannula - Accessory
DSG Threaded Drill Starter Pin
DSG Connect Handle
DSG Connect App
PediGuard DSG Connect
DSG Handle
Needle XS
Cannulated PsiFGuard
Cannulated PediGuard Stylet Bevel - 120mm
PediGuard DSG Threaded Shaft
PediGuard DSG Ratcheting Handle
Cannulated Pediguard Stylet - Bevel
Cannulated PediGuard Stylet - Trocar
Cannulated PediGuard Stylet - Trocar - 120mm
PediGuard XS
PediGuard Needle#1
PediGuard Curv
PediGuard Handle
PediGuard Needle
PediGuard Tri-Tip
PediGuard Curv XS
PediGuard Needle #2
DSG Zavation Screw System
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility