510(k) K250374 ยท HBE Drills, Burrs, Trephines & Accessories (Simple, Powered)
iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D); iBur 3.0mm Precision Round, Distal Bend (8431-009-030); iBur 4.0mm Precision Round, Distal Bend (8431-009-040); iBur 2.0mm Diamond Round, Distal Bend (8431-012-020D); iBur 3.0mm Diamond Round, Distal Bend (8431-012-030D); iBur 4.0mm Diamond
| Applicant | Stryker Instruments, Portage MI, US |
| Decision | Substantially Equivalent, Mar 11, 2025 |
| Received | Feb 10, 2025 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K250374
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.