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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 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 2018-11-01 under 510(k) 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. The listed applicant is Synthes (Usa) Products, LLC / Depuy Orthopaedics, Inc.. The 510(k) number is K180310.

When did DePuy Synthes Trauma Orthopedic Plates and Screws receive FDA 510(k) clearance?

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

Who is the listed applicant for DePuy Synthes Trauma Orthopedic Plates and Screws?

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 Trauma Orthopedic Plates and Screws?

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

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 ScrewsK181933DePuy Synthes Sterilization Container SystemK172975DePuy 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: HRS)

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.

K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.K261511Xpert AnkleNewclip TechnicsK261406Versalock Proximal Tibial Plating SystemGM Dos Reis Industria e Comercio Ltda.K262032TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB )TriMed, Inc.K261191Alians Elbow SNewclip TechnicsK261054RibPlate SystemStryker Leibinger GmbH & Co KG

Official Source

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

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