FDA Registration
Active
🇩🇪 Germany
Control Gauges
Reg #: 3012764194
·
FEI: 3012764194
·
Expires 2025
Products
1
Proprietary Names
21
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Silony Medical International AG
- Registration Number
- 3012764194
- FEI Number
- 3012764194
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Leinfelder Strasse 60
- City
- Leinfelden Echterdingen Baden-Wurttemberg
- Country
- DE
Owner / Operator
- Firm Name
- Silony Medical
- Operator Number
- 10054311
- Address
- Leinfelder Strasse 60
- City
- Leinfelden-Echterdingen
- State
- Baden-Wurttemberg
- Postal Code
- 70771
- Country
- DE
US Agent
- Business Name
- RAF SOLUTIONS USA, INC
- Contact Name
- Edwin Lindsay
- Address
- 10124 N.W. 53rd Street, Sunrise
- City
- Fort Lauderdale
- State
- FL
- ZIP
- 33351
- Country
- US
- [email protected]
- Phone
- 305 9607262
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2017-03-21 |
Proprietary Names
Control Gauges
Guiding instruments
Pusher
Shaver
Frames
Forceps
Torque Limiter
Paddle Sizer
Implant modifier
(Re-)Positioning Tools
Handle
Loading Block
Scraper
Working Tower
Counter Torque
Adapter
Orthopedic manual surgical instrument
Inserter
Drill Guide
Dilatator
Distractor
Establishment Types
Export Device to the United States But Perform No Other Operation on Device