iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D) +8 more— 510(k) K250374
Substantially EquivalentStryker Instruments
FDA 510(k) clearance K250374 for iBur 3.0mm Diamond Match Head, Distal Bend (8431-107-030D) +8 more, Substantially Equivalent on 2025-03-11. Applicant: Stryker Instruments. Device class: 2.
Clearance details
- Device name as filed
- 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
- Product code
- Code HBE
- Device class
- Class 2
- Regulation
- 21 CFR 882.4310
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Portage, MI, US
Recent devices under product code HBE
view allMore clearances from Stryker Instruments
view allAdverse events under product code HBE
product code HBE- Injury
- 306
- Malfunction
- 7,175
- Other
- 1
- Total
- 7,482
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.