FDA 510(k)

NEOVIEW Plating System

K-Number: K160995 · 2016-06-10

Decision Date2016-06-10

Product CodeHRS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

NEOVIEW Plating System is the device name listed in this FDA 510(k) record. The listed applicant is In2bones Sas. It received FDA 510(k) clearance on 2016-06-10 under 510(k) number K160995. 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 NEOVIEW Plating System?

NEOVIEW Plating System is a medical device that received FDA 510(k) clearance on 2016-06-10. The listed applicant is In2bones Sas. The 510(k) number is K160995.

When did NEOVIEW Plating System receive FDA 510(k) clearance?

NEOVIEW Plating System received FDA 510(k) clearance on 2016-06-10, under 510(k) number K160995.

Who is the listed applicant for NEOVIEW Plating System?

The FDA 510(k) record lists In2bones Sas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEOVIEW Plating System?

The FDA product code for NEOVIEW Plating System is HRS.

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Related Devices (Code: HRS)

K260277MIKRON TRAUMA BONE PLATE& SCREW SYSTEMMikron Makina San. ve Tic. Ltd. Sti.K261511Xpert AnkleNewclip Technics K261406Versalock 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 Technics K261054RibPlate 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.