FDA Registration
Active
🇺🇸 United States
SkyWalker Total Knee System
Reg #: 3018565653
·
FEI: 3018565653
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- MICROPORT NAVIBOT
- Registration Number
- 3018565653
- FEI Number
- 3018565653
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 5677 Airline Rd
- City
- Arlington
- State
- TN
- ZIP
- 38002
- Country
- US
Regulatory Submissions
- 510(k) Number
- K213873
Owner / Operator
- Firm Name
- MicroPort NaviBot
- Operator Number
- 10085741
- Address
- 5677 Airline Road
- City
- Arlington
- State
- TN
- Postal Code
- 38002
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2022-07-28 |
Proprietary Names
SkyWalker Total Knee System
Establishment Types
Manufacture Medical Device