Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

DePuy Synthes Plates and Screws Portfolio

K-Number: K190750 · 2019-06-21

ApplicantDePuy Synthes
Decision Date2019-06-21
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DePuy Synthes Plates and Screws Portfolio is the device name listed in this FDA 510(k) record. The listed applicant is DePuy Synthes. It received FDA 510(k) clearance on 2019-06-21 under 510(k) number K190750. 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 Plates and Screws Portfolio?

DePuy Synthes Plates and Screws Portfolio is a medical device that received FDA 510(k) clearance on 2019-06-21. The listed applicant is DePuy Synthes. The 510(k) number is K190750.

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

DePuy Synthes Plates and Screws Portfolio received FDA 510(k) clearance on 2019-06-21, under 510(k) number K190750.

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

The FDA 510(k) record lists DePuy Synthes as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing DePuy Synthes 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.

K233696DePuy Synthes Retrograde Femoral Nail Advanced SystemK233256Robotic Integration InstrumentsK233255CROSSNAV Navigation Enabled InstrumentsK233254TELIGEN System Navigation Ready InstrumentsK233665DePuy Synthes VOLT Mini Fragment Plating System, DePuy Synthes VOLT Small Fragment Plating SystemK231922DEPUY SYNTHES MAXFRAME AUTOSTRUT System

View all 18 devices →

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

View on FDA Database →

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

↑