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FDA 510(k)

ORTHOLOC® 3Di Ankle Fracture Plating System

K-Number: K163044 · 2017-01-26

ApplicantWrightmedicaltechnologyinc
Decision Date2017-01-26
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORTHOLOC® 3Di Ankle Fracture Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Wrightmedicaltechnologyinc. It received FDA 510(k) clearance on 2017-01-26 under 510(k) number K163044. 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 ORTHOLOC® 3Di Ankle Fracture Plating System?

ORTHOLOC® 3Di Ankle Fracture Plating System is a medical device that received FDA 510(k) clearance on 2017-01-26. The listed applicant is Wrightmedicaltechnologyinc. The 510(k) number is K163044.

When did ORTHOLOC® 3Di Ankle Fracture Plating System receive FDA 510(k) clearance?

ORTHOLOC® 3Di Ankle Fracture Plating System received FDA 510(k) clearance on 2017-01-26, under 510(k) number K163044.

Who is the listed applicant for ORTHOLOC® 3Di Ankle Fracture Plating System?

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

What is the FDA product code for ORTHOLOC® 3Di Ankle Fracture Plating System?

The FDA product code for ORTHOLOC® 3Di Ankle Fracture Plating System is HRS.

Related Clinical Trials

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NCT07511478Fibula Plating vs Intramedullary K-Wire in Bimalleolar Ankle FracturesCOMPLETED

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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.

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