Intellijoint Surgical, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 7
- Inspections
- 1
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1559-2020 | Class II | Intellijoint Navigation System, Software Application, IJK1 (P/N 000-0547) - Product Usage: The Intel | February 11, 2020 |
| Z-2228-2019 | Class II | Workstation, G2, Configured (P/N 000-0241) | June 28, 2019 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K211876 | Intellijoint VIEW | November 12, 2021 |
| K191507 | Intellijoint® Navigation System | October 1, 2019 |
| K172849 | Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP Instrument Tray | November 16, 2017 |
| K171525 | Intellijoint HIP Generation 2B System | October 30, 2017 |
| K162364 | Intellijoint HIP Generation 2A System | March 2, 2017 |
| K151364 | Intellijoint HIP(tm) System | December 28, 2015 |
| K133759 | INTELLIJOINT HIP | July 23, 2014 |