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FDA 510(k)

DePuy Synthes Trauma Orthopedic Plates and Screws

K-Number: K180310 · 2018-11-01

ApplicantSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.
Decision Date2018-11-01
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DePuy Synthes Trauma Orthopedic Plates and Screws is a medical device manufactured by Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.. It received FDA 510(k) clearance on 2018-11-01 under approval number K180310. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DePuy Synthes Trauma Orthopedic Plates and Screws?

DePuy Synthes Trauma Orthopedic Plates and Screws is a medical device that received FDA 510(k) clearance on 2018-11-01. It is manufactured by Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.. The 510(k) number is K180310.

When was DePuy Synthes Trauma Orthopedic Plates and Screws approved by the FDA?

DePuy Synthes Trauma Orthopedic Plates and Screws received FDA 510(k) clearance on 2018-11-01, under approval number K180310.

What company makes DePuy Synthes Trauma Orthopedic Plates and Screws?

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

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

The FDA product code for DePuy Synthes Trauma Orthopedic Plates and Screws is HRS.

Related Clinical Trials

NCT06938607 Post-operative Outcomes of Anterior Cervical Discectomy and Fusion Surgery With and Without Drain Placement NOT_YET_RECRUITING NCT07336277 Sleep Quality and the Efficacy of a Multimodal Sleep Pathway in Hospitalized Orthopedic Trauma Patients NOT_YET_RECRUITING NCT07502885 Deep Phenotyping Gait Deficits in Orthopedic Manifestations of Pediatric Cancer Patients RECRUITING NCT04103502 In Vivo Kinematics for Subjects Having a MicroPort Medial Pivot or DePuy Attune PCR TKA WITHDRAWN NCT07515092 Virtual Reality-Based Simulation Training for Antegrade Anterior Column Acetabular Screw Placement in Orthopedic Residents ENROLLING_BY_INVITATION 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 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 K192745DePuy Synthes Trauma Screws K181933DePuy Synthes Sterilization Container System

Related Devices (Code: HRS)

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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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