510(k) K243889 ยท JXI Cuff, Nerve
Remplir (ON-152, 15 x 20 mm); Remplir (ON-203, 20 x 30 mm); Remplir (ON-304, 30 x 40 mm); Remplir (ON-405, 40 x 50 mm)
| Applicant | Orthocell, Ltd., Murdoch, AU |
| Decision | Substantially Equivalent, Apr 2, 2025 |
| Received | Dec 18, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243889
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.