IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools— 510(k) K170312
Substantially EquivalentMedtronic Powered Surgical Solutions
FDA 510(k) clearance K170312 for IPC systems, Legend EHS handpieces and Legend Stylus Touch handpiece, Microsaw handpieces,Triton electric high torque handpiece, Attachments and surgical dissecting tools, Substantially Equivalent on 2017-05-15. Applicant: Medtronic Powered Surgical Solutions.
Clearance details
- Applicant
- Medtronic Powered Surgical Solutions
- Product code
- Code HBC
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fort Worth, TX, US
Adverse events under product code HBC
product code HBC- Malfunction
- 4,715
- Total
- 4,715
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.