DePuy Synthes Trauma Screws— 510(k) K192745
Substantially EquivalentSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.
FDA 510(k) clearance K192745 for DePuy Synthes Trauma Screws, Substantially Equivalent on 2019-11-26. Applicant: Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.. Device class: 2.
Clearance details
- Applicant
- Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.
- Product code
- Code HWC
- Device class
- Class 2
- Regulation
- 21 CFR 888.3040
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Chester, PA, US
Recent devices under product code HWC
view allMore clearances from Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.
view all- K181933 — DePuy Synthes Sterilization Container System
- K180310 — DePuy Synthes Trauma Orthopedic Plates and Screws
- K172975 — DePuy Synthes (USA) 5.0mm / 7.3mm Crimp Positioning Pins MR Conditional, DePuy Synthes Variable Angle Positioning Pins MR Conditional, DePuy Synthes Wire Mount MR Conditional, DePuy Synthes Cerclage Positioning Pin MR Conditional
- K160553 — DePuy Synthes 4.0 mm and 5.0 mm Locking Screws MR Conditional, DePuy Synthes Wrist Fusion Plate (WFP) MR Conditional, DePuy Synthes Large Fragment Dynamic Compression Locking (DCL) System MR Conditional, DePuy Synthes Small Fragment Dynamic Compression Locking (DCL) System MR Conditional, DePuy Synthes Modular Foot System MR Conditional, DePuy Synthes T-Plates MR Conditional, DePuy Synthes One-third Tubular Plate with Collar (OTPC) MR Conditional, DePuy Synthes Stainless S
Adverse events under product code HWC
product code HWC- Death
- 20
- Injury
- 15,910
- Malfunction
- 8,192
- Other
- 1
- Total
- 24,123
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.