K993074
Substantially EquivalentSMART NAIL MODELS 521516, 521520,521525, 531516, 531520. 531525
- Applicant
- Bionx Implants, Ltd.
- Product code
- MAI
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tampere, FI
Adverse events under product code MAI
product code MAI- Injury
- 1,948
- Malfunction
- 8,580
- Total
- 10,528
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.