FDA 510(k)

VLP MINI-MOD 2.0mm Column Plates

K-Number: K163086 · 2016-12-21

Decision Date2016-12-21

Product CodeHRS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

VLP MINI-MOD 2.0mm Column Plates is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc.. It received FDA 510(k) clearance on 2016-12-21 under 510(k) number K163086. 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 VLP MINI-MOD 2.0mm Column Plates?

VLP MINI-MOD 2.0mm Column Plates is a medical device that received FDA 510(k) clearance on 2016-12-21. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K163086.

When did VLP MINI-MOD 2.0mm Column Plates receive FDA 510(k) clearance?

VLP MINI-MOD 2.0mm Column Plates received FDA 510(k) clearance on 2016-12-21, under 510(k) number K163086.

Who is the listed applicant for VLP MINI-MOD 2.0mm Column Plates?

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

What is the FDA product code for VLP MINI-MOD 2.0mm Column Plates?

The FDA product code for VLP MINI-MOD 2.0mm Column Plates is HRS.

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Other records listing Smith & Nephew, Inc. as applicant

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Related Devices (Code: HRS)

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 K261351SALGINA 2.5mm Distal Radius SystemBonebridge AG

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.