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. Device class: 2.
Clearance details
- Applicant
- Synthes (USA) Products, LLC
- Product code
- Code HRS
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Chester, PA, US
Recent devices under product code HRS
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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.