510(k) K230655 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
PEEK RCI Screw; Bio-Composite Screw; SignaLoc Screw
| Applicant | Signature Orthopaedics Pty, Ltd., Lane Cove West, AU |
| Decision | Substantially Equivalent, May 3, 2023 |
| Received | Mar 9, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K230655
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.