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— 510(k) K160553
Substantially EquivalentSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.
FDA 510(k) clearance K160553 for 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, Substantially Equivalent on 2017-06-30. Applicant: Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.. Device class: 2.
Clearance details
- Applicant
- Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.
- Product code
- Product 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
view allMore clearances from Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.
view all- K192745 — DePuy Synthes Trauma Screws
- 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
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.