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FDA 510(k)

DePuy Synthes Sterilization Container System

K-Number: K181933 · 2019-05-09

ApplicantSynthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.
Decision Date2019-05-09
Product CodeKCT
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

DePuy Synthes Sterilization Container System is a medical device manufactured by Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.. It received FDA 510(k) clearance on 2019-05-09 under approval number K181933. The device is classified under product code KCT. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DePuy Synthes Sterilization Container System?

DePuy Synthes Sterilization Container System is a medical device that received FDA 510(k) clearance on 2019-05-09. It is manufactured by Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.. The 510(k) number is K181933.

When was DePuy Synthes Sterilization Container System approved by the FDA?

DePuy Synthes Sterilization Container System received FDA 510(k) clearance on 2019-05-09, under approval number K181933.

What company makes DePuy Synthes Sterilization Container System?

DePuy Synthes Sterilization Container System is manufactured by Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc..

What is the FDA product code for DePuy Synthes Sterilization Container System?

The FDA product code for DePuy Synthes Sterilization Container System is KCT.

Related Clinical Trials

NCT01143558 Searching for Persistence of Infection in Lyme Disease COMPLETED NCT04610294 Operating Room Air Filtration/Sterilization ACTIVE_NOT_RECRUITING

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 K192745DePuy Synthes Trauma Screws

Related Devices (Code: KCT)

K160574K3PRO SURGICAL TRAYArgon Med. Productions Vertriebs Gesellschaft Mbh CO KG K162600Jewel Precision Reusable Rigid Sterilization Container SystemJewel Precision Sheet Metal & Machine, Inc. K160912Sterilization TraySTERIS Corporation K161347Signia sterilization trayCovidien K152745ReNew Sterilization Trays(Catalog #3708 and #3709)Microline Surgical, Inc. K152111Symmetry Surgical Quad-Lock Container SystemSymmetry Surgical, Inc.

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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