FDA 510(k)

VLP Wrist Fracture System

K-Number: K161665 · 2016-11-15

Decision Date2016-11-15

Product CodeHRS

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

VLP Wrist Fracture System 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 2016-11-15 under 510(k) number K161665. 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 Wrist Fracture System?

VLP Wrist Fracture System is a medical device that received FDA 510(k) clearance on 2016-11-15. The listed applicant is Smith & Nephew, Inc.. The 510(k) number is K161665.

When did VLP Wrist Fracture System receive FDA 510(k) clearance?

VLP Wrist Fracture System received FDA 510(k) clearance on 2016-11-15, under 510(k) number K161665.

Who is the listed applicant for VLP Wrist Fracture System?

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 Wrist Fracture System?

The FDA product code for VLP Wrist Fracture System 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.