K243565
Substantially EquivalentDYNAMIS SI Screw System
- Applicant
- Promethean Restorative, LLC
- Product code
- OUR
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Castle Rock, CO, US
Adverse events under product code OUR
product code OUR- Death
- 3
- Injury
- 347
- Total
- 350
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.