Data / Medical devices / United States / Microport Navibot International LLC
Microport Navibot International LLC: FDA-registered device maker in Arlington, TN, United States, 1 510(k) clearance
Microport Navibot International LLC is registered with the FDA (registration 3018565653) in Arlington, TN, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 7, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3018565653
- Address
- 5677 Airline Rd, Arlington, TN, United States, 38002
- Owner or operator
- MicroPort NaviBot (10085741)
- Roles
- Manufacturer
- First device listed
- July 28, 2022
- Registered through
- 2026
- Brand names listed
- SkyWalker Total Knee System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Orthopedic Stereotaxic Instrument | OLO | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 7, 2022 | K213873 | SkyWalker Total Knee System | OLO | Substantially Equivalent | Microport Navibot International, LLC | accessdata.fda.gov |
Compare with other makers
Updated July 7, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.