DePuy Synthes Trauma Orthopedic Plates and Screws— 510(k) K180310
Substantially EquivalentSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.
FDA 510(k) clearance K180310 for DePuy Synthes Trauma Orthopedic Plates and Screws, Substantially Equivalent on 2018-11-01. Applicant: Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc..
Clearance details
- Applicant
- Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.
- 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.