K250374
- 510(k) number
- K250374
- Device name
- 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 Round, Distal Bend (8431-012-040D); iBur 3.0mm Coarse Diamond Round, Distal Bend (8431-013-030DC); iBur 4.0mm Coarse Diamond Round, Distal Bend (8431-013-040DC); iBur 5.0mm Coarse Diamond R
- Applicant
- Stryker Instruments MI · US
- Product code
- HBE — Drills, Burrs, Trephines & Accessories (Simple, Powe
- Decision date
- 2025-03-11
- Date received
- 2025-02-10
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Neurology
PDFDownload 510(k) SummaryArchived here · 3.1 MB · U.S. public domain
Also available from FDA: K250374.pdf
Official FDA record: K250374
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.