510(k) K180191 ยท GAT Suture, Nonabsorbable, Synthetic, Polyethylene
SuperBall Meniscal Repair System
| Applicant | Arcuro Medical , Ltd., Misgav, IL |
| Decision | Substantially Equivalent, Jun 5, 2018 |
| Received | Jan 23, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180191
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.