Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories— 510(k) K163182
Substantially EquivalentMedtronic Powered Surgical Solutions
FDA 510(k) clearance K163182 for Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System Accessories, Substantially Equivalent on 2017-03-23. Applicant: Medtronic Powered Surgical Solutions.
Clearance details
- Applicant
- Medtronic Powered Surgical Solutions
- Product code
- Code HBB
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Fort Worth, TX, US
Adverse events under product code HBB
product code HBB- Malfunction
- 2,656
- Total
- 2,656
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.