FOCUS Pedicle Screw System— 510(k) K180458
Substantially EquivalentNvision Biomedical Technologies, LLC
FDA 510(k) clearance K180458 for FOCUS Pedicle Screw System, Substantially Equivalent on 2018-04-17. Applicant: Nvision Biomedical Technologies, LLC.
Clearance details
- Applicant
- Nvision Biomedical Technologies, LLC
- Product code
- Code NKB
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Antonio, TX, US
Adverse events under product code NKB
product code NKB- Death
- 27
- Injury
- 5,033
- Malfunction
- 4,140
- Total
- 9,200
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.