510(k) K192465 ยท JEC Component, Traction, Invasive
DigiFix Sterile Kit
| Applicant | Virak Orthopedics, LLC, Harrison NJ, US |
| Decision | Substantially Equivalent, Oct 10, 2019 |
| Received | Sep 9, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K192465
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.