Multi-Drive Interference Screw System— 510(k) K200428
Substantially EquivalentNvision Biomedical Technologies, Inc.
FDA 510(k) clearance K200428 for Multi-Drive Interference Screw System, Substantially Equivalent on 2020-11-10. Applicant: Nvision Biomedical Technologies, Inc..
Clearance details
- Applicant
- Nvision Biomedical Technologies, Inc.
- Product code
- Code MBI
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Antonio, TX, US
Adverse events under product code MBI
product code MBI- Injury
- 3,163
- Malfunction
- 13,006
- Other
- 2
- Total
- 16,171
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.