Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set— 510(k) K212756
Substantially EquivalentMedos International SARL
FDA 510(k) clearance K212756 for Discectomy Navigation Ready Instruments and Universal Navigation Adaptor Set, Substantially Equivalent on 2022-05-05. Applicant: Medos International SARL.
Clearance details
- Applicant
- Medos International SARL
- Product code
- Code OLO
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Le Locle, CH
Adverse events under product code OLO
product code OLO- Death
- 11
- Injury
- 2,799
- Malfunction
- 11,105
- Other
- 1
- Total
- 13,916
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.