FDA Registration
Active
🇺🇸 United States
Avenger Radial Head System
Reg #: 3011580264
·
FEI: 3011580264
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- IN2BONES USA, LLC
- Registration Number
- 3011580264
- FEI Number
- 3011580264
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 6000 POPLAR AVE STE 115
- City
- Memphis
- State
- TN
- ZIP
- 38119
- Country
- US
Regulatory Submissions
- 510(k) Number
- K192754
Owner / Operator
- Firm Name
- In2Bones USA, LLC
- Operator Number
- 10049042
- Address
- 6000 Poplar Ave, Suite 115
- City
- Memphis
- State
- TN
- Postal Code
- 38119
- Country
- US
- Correspondent
- Robert K Buchanan
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Prosthesis, Elbow, Hemi-, Radial, Polymer | KWI | Class 2 | Orthopedic | No | 2020-02-14 |
Proprietary Names
Avenger Radial Head System
Establishment Types
Manufacture Medical Device