510(k) K201704 ยท PEK Spinous Process Plate
CoFix System
| Applicant | Paradigm Spine GmbH, Marquette MI, US |
| Decision | Substantially Equivalent, Aug 4, 2020 |
| Received | Jun 22, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K201704
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.