510(k) K261651— Precice Max System and Precice Ankle Salvage System
Substantially EquivalentNuVasive Specialized Orthopedics
Clearance details
- Applicant
- NuVasive Specialized Orthopedics
- Product code
- Code HSB
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Audubon, PA, US
Adverse events under product code HSB
product code HSB- Death
- 49
- Injury
- 12,083
- Malfunction
- 6,561
- Other
- 1
- Total
- 18,694
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.