510(k) K182352 · PEK Spinous Process Plate
SP-LINK System
| Applicant | Medical Designs, LLC, Sioux Falls SD, US |
| Decision | Substantially Equivalent, Nov 21, 2018 |
| Received | Aug 29, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182352
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.