FDA Registration
Active
🇩🇪 Germany
Spinendos GmbH
Reg #: 3009499159
·
FEI: 3009499159
·
Expires 2026
Products
23
Proprietary Names
3
Establishment Types
1
Classifications
23
Registration Details
- Registration Name
- Spinendos GmbH
- Registration Number
- 3009499159
- FEI Number
- 3009499159
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Landsberger Strasse 398
- City
- Muenchen Bavaria
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K130778
Owner / Operator
- Firm Name
- Spinendos GmbH
- Operator Number
- 10038995
- Address
- Landsberger Strasse 398
- City
- Muenchen
- State
- Bavaria
- Postal Code
- 81241
- Country
- DE
US Agent
- Business Name
- MEDAGENT Inc.
- Contact Name
- Franz Menean
- Address
- 264 Lafayette Rd Ste 7
- City
- Portsmouth
- State
- NH
- ZIP
- 03801
- Country
- US
- [email protected]
- Phone
- 603 5702039
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Rongeur | HTX | Class 1 | Orthopedic | No | 2011-12-01 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2011-12-01 |
| Camera, Television, Endoscopic, Without Audio | FWF | Class 1 | General, Plastic Surgery | No | 2011-12-01 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 2011-12-01 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2014-04-17 |
| Knife, Surgical | EMF | Class 1 | General, Plastic Surgery | No | 2011-12-01 |
| Dissector, Surgical, General & Plastic Surgery | GDI | Class 1 | General, Plastic Surgery | No | 2011-12-01 |
| Holder, Needle; Orthopedic | HXK | Class 1 | Orthopedic | No | 2011-12-01 |
| Probe | HXB | Class 1 | Orthopedic | No | 2011-12-01 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2011-12-01 |
| Syringe, Irrigating (Non Dental) | KYZ | Class 1 | General Hospital | No | 2011-12-01 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2011-12-01 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 2011-12-01 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2018-05-16 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2011-12-01 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2011-12-01 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 2011-12-01 |
| Trephine | HWK | Class 1 | Orthopedic | No | 2011-12-01 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2011-12-01 |
| Accessories, Arthroscopic | NBH | Class 1 | Orthopedic | No | 2011-12-01 |
| Mallet | HXL | Class 1 | General, Plastic Surgery | No | 2011-12-01 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2011-12-01 |
| Scissors, General, Surgical | LRW | Class 1 | General, Plastic Surgery | No | 2011-12-01 |
Proprietary Names
Discoscope
Cercival Endoscope
Instrument Tray
Establishment Types
Repack or Relabel Medical Device