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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 the device name listed in this FDA 510(k) record. The listed applicant is Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.. It received FDA 510(k) clearance on 2019-05-09 under 510(k) 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. The listed applicant is Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.. The 510(k) number is K181933.

When did DePuy Synthes Sterilization Container System receive FDA 510(k) clearance?

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

Who is the listed applicant for DePuy Synthes Sterilization Container System?

The FDA 510(k) record lists Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K192745DePuy Synthes Trauma ScrewsK180310DePuy Synthes Trauma Orthopedic Plates and ScrewsK172975DePuy 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 ConditionalK160553DePuy 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

Related Devices (Code: KCT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253187SteriBest® Sterilization Tray SystemMastel SurgicalK260726Straumann® ProClean™ Cassette (041.800 ; 041.801)Institut Straumann AGK252854SteriTite Container System with MediTray ProductsCase Medical, Inc.K253791PUREVUE™ Quick Connect Cannula System Tray; PUREVUE™ Quick Connect Cannula System LidDePuy Mitek, Inc.K251614Stainless Steel Surgical KitsDentsply Sirona, Inc.K251756Sterilization TraysParagon Implant Mfg., LLC

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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