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FDA 510(k)

G3™ Active Plate® Miniature System

K-Number: K171293 · 2017-10-23

ApplicantGenesis Fracture Care, Inc.
Decision Date2017-10-23
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

G3™ Active Plate® Miniature System is the device name listed in this FDA 510(k) record. The listed applicant is Genesis Fracture Care, Inc.. It received FDA 510(k) clearance on 2017-10-23 under 510(k) number K171293. 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 G3™ Active Plate® Miniature System?

G3™ Active Plate® Miniature System is a medical device that received FDA 510(k) clearance on 2017-10-23. The listed applicant is Genesis Fracture Care, Inc.. The 510(k) number is K171293.

When did G3™ Active Plate® Miniature System receive FDA 510(k) clearance?

G3™ Active Plate® Miniature System received FDA 510(k) clearance on 2017-10-23, under 510(k) number K171293.

Who is the listed applicant for G3™ Active Plate® Miniature System?

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

What is the FDA product code for G3™ Active Plate® Miniature System?

The FDA product code for G3™ Active Plate® Miniature System is HRS.

Other records listing Genesis Fracture Care, 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.

K160633G3(TM) Active Plate(R) Small Fragment 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

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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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