510(k) K212755 · HWC Screw, Fixation, Bone
SIGNUS SACRONAIL® Transsacral Stabilization System
| Applicant | Signus Medizintechnik GmbH, Alzenau, DE |
| Decision | Substantially Equivalent, Mar 10, 2022 |
| Received | Aug 31, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212755
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.