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FDA 510(k)

DePuy Synthes Trauma Screws

K-Number: K192745 · 2019-11-26

ApplicantSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.
Decision Date2019-11-26
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DePuy Synthes Trauma Screws is a medical device manufactured by Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.. It received FDA 510(k) clearance on 2019-11-26 under approval number K192745. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DePuy Synthes Trauma Screws?

DePuy Synthes Trauma Screws is a medical device that received FDA 510(k) clearance on 2019-11-26. It is manufactured by Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.. The 510(k) number is K192745.

When was DePuy Synthes Trauma Screws approved by the FDA?

DePuy Synthes Trauma Screws received FDA 510(k) clearance on 2019-11-26, under approval number K192745.

What company makes DePuy Synthes Trauma Screws?

DePuy Synthes Trauma Screws is manufactured by Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc..

What is the FDA product code for DePuy Synthes Trauma Screws?

The FDA product code for DePuy Synthes Trauma Screws is HWC. This falls under the Cardiovascular category.

Related Clinical Trials

NCT05565131 Performance Measurement and Safety Evaluation of the PYTHEAS® ODYSSEE Angular Assistance System for Intra-pedicular Screw Placement in Adult Spine Surgery COMPLETED

Other Devices by Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.

K160553DePuy 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 K180310DePuy Synthes Trauma Orthopedic Plates and Screws K172975DePuy 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 K181933DePuy Synthes Sterilization Container System

Related Devices (Code: HWC)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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