510(k) K222589 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
Flexible Suturing System with Anchors (FSSA)
| Applicant | Integrity Orthopaedics, Inc., Maple Plain MN, US |
| Decision | Substantially Equivalent, Jan 26, 2023 |
| Received | Aug 26, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K222589
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.