Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws)— 510(k) K150099
Substantially EquivalentSynthes (USA) Products, LLC
FDA 510(k) clearance K150099 for Depuy Synthes Variable Angle Locking Hand System (1.3 mm and 2.0 mm Plates and Screws), Substantially Equivalent on 2015-03-23. Applicant: Synthes (USA) Products, LLC.
Clearance details
- Applicant
- Synthes (USA) Products, LLC
- Product code
- Code HRS
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Chester, PA, US
Adverse events under product code HRS
product code HRS- Death
- 27
- Injury
- 10,340
- Malfunction
- 3,328
- Total
- 13,695
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.