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)

Avanti Distal Radius and Forearm System

K-Number: K191118 · 2019-12-13

ApplicantAvanti Orthopaedics, Inc.
Decision Date2019-12-13
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Avanti Distal Radius and Forearm System is the device name listed in this FDA 510(k) record. The listed applicant is Avanti Orthopaedics, Inc.. It received FDA 510(k) clearance on 2019-12-13 under 510(k) number K191118. 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 Avanti Distal Radius and Forearm System?

Avanti Distal Radius and Forearm System is a medical device that received FDA 510(k) clearance on 2019-12-13. The listed applicant is Avanti Orthopaedics, Inc.. The 510(k) number is K191118.

When did Avanti Distal Radius and Forearm System receive FDA 510(k) clearance?

Avanti Distal Radius and Forearm System received FDA 510(k) clearance on 2019-12-13, under 510(k) number K191118.

Who is the listed applicant for Avanti Distal Radius and Forearm System?

The FDA 510(k) record lists Avanti Orthopaedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Avanti Distal Radius and Forearm System?

The FDA product code for Avanti Distal Radius and Forearm System is HRS.

Related Clinical Trials

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.

NCT05156749Short and Long-arm Fiberglass Cast Immobilization for Distal Salter Harris I and II Forearm Fractures in ChildrenRECRUITING

Other records listing Avanti 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.

K261145Avanti Distal Elbow ORIF SystemK222967Avanti Orthopaedics 2.2mm and 2.7mm Cannulated Screws, Avanti Orthopaedics 3.2mm and 4.0mm Cannulated ScrewsK211592Avanti Orthopaedics Ulnar Shortening System

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.

↑