FDA Registration
Active
🇩🇪 Germany
BonOs Inject
Reg #: 9615014
·
FEI: 3005568854
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
1
Classifications
4
Registration Details
- Registration Name
- OSARTIS GMBH
- Registration Number
- 9615014
- FEI Number
- 3005568854
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Auf der Beune 101
- City
- Muenster Hesse
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K202458
Owner / Operator
- Firm Name
- OSARTIS GmbH
- Operator Number
- 10055041
- Address
- Auf der Beune 101
- City
- Muenster
- State
- Hesse
- Postal Code
- 64839
- Country
- DE
- Correspondent
- Volker Stirnal
US Agent
- Business Name
- Brauer Device Consultants, LLC
- Contact Name
- Christine L. Brauer
- Address
- 7 Trail House Court
- City
- Rockville
- State
- MD
- ZIP
- 20850
- Country
- US
- [email protected]
- Phone
- 301 5451993
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bone Cement | LOD | Class 2 | Orthopedic | No | 2021-07-13 |
| Cement, Bone, Vertebroplasty | NDN | Class 2 | Orthopedic | No | 2021-07-13 |
| Bone Cement, Posterior Screw Augmentation | PML | Class 2 | Orthopedic | No | 2021-07-13 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2021-07-13 |
Proprietary Names
BonOs Inject
Establishment Types
Manufacture Medical Device