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FDA 510(k)

Pantheon Medical Balanced Plating System

K-Number: K162154 · 2017-04-24

ApplicantPantheon Medical
Decision Date2017-04-24
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Pantheon Medical Balanced Plating System is the device name listed in this FDA 510(k) record. The listed applicant is Pantheon Medical. It received FDA 510(k) clearance on 2017-04-24 under 510(k) number K162154. 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 Pantheon Medical Balanced Plating System?

Pantheon Medical Balanced Plating System is a medical device that received FDA 510(k) clearance on 2017-04-24. The listed applicant is Pantheon Medical. The 510(k) number is K162154.

When did Pantheon Medical Balanced Plating System receive FDA 510(k) clearance?

Pantheon Medical Balanced Plating System received FDA 510(k) clearance on 2017-04-24, under 510(k) number K162154.

Who is the listed applicant for Pantheon Medical Balanced Plating System?

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

What is the FDA product code for Pantheon Medical Balanced Plating System?

The FDA product code for Pantheon Medical Balanced Plating System is HRS.

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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