FDA Registration
Active
🇩🇪 Germany
ROCCIA Probe/Trial
Reg #: 3012764194
·
FEI: 3012764194
·
Expires 2025
Products
1
Proprietary Names
6
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 |
|---|---|---|---|---|---|
| Probe | HXB | Class 1 | Orthopedic | No | 2017-03-21 |
Proprietary Names
ROCCIA Probe/Trial
VERTICALE Probe/Trial
SPECIALS Trial
FAVO S-TLIF Trial
Oyster ACIF Trial
VERTICALE CERVICAL Probe/Trial
Establishment Types
Export Device to the United States But Perform No Other Operation on Device