510(k) K193256 ยท JEC Component, Traction, Invasive
Anjon Bremer Halo System
| Applicant | Anjon Holdings, LLC, Jacksonville FL, US |
| Decision | Substantially Equivalent, Mar 2, 2020 |
| Received | Nov 26, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193256
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 18, 2020 | Anjon Holdings Anjon Bremer Molded Crown. bone fixation fastener for spinal use. REF number 100048 - Product Usage: Smooth or threaded metallic bone fixation fastener. Provides cervical spine immobilization and the Terminated |
JEC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.