OSSEODUO Shaver and Drill System— 510(k) K173066
Substantially EquivalentBien-Air Surgery SA
FDA 510(k) clearance K173066 for OSSEODUO Shaver and Drill System, Substantially Equivalent on 2018-06-22. Applicant: Bien-Air Surgery SA.
Clearance details
- Applicant
- Bien-Air Surgery SA
- Product code
- Code HBC
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Le Noirmont, CH
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.