Wrist Fusion Plate

FDA 510(k) K052754 · Dvo Extremity Solutions, LLC

Substantially Equivalent

510(k) numberK052754

Submission

Device name
Wrist Fusion Plate
Applicant
Dvo Extremity Solutions, LLC
Derby, CT, US
Received
September 30, 2005
Decision date
October 27, 2005
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LXT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3030
Specialty
Orthopedic
Implant
Yes

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K230067Para-Fix External Fixation SystemLXT · Traditional New Paradigm Biomedical09/22/2023SE
K131636Polarus ConnectLXT · Traditional Acumed, LLC10/10/2013SE
K132704Distal Radius Volar Rim Plate Standard, Distal Radius Volar Rim Plate NarrowLXT · Traditional Biomet10/09/2013SE
K112345Distal Volar Radius Plating SystemsLXT · Traditional Medos International SARL10/31/2011SE
K090374Sterile DVR Anatomic Plates Various Configurations) Model (S) 131212001,2, 5-10 2.5MM…LXT · Special DePuy Orthopaedics, Inc.03/11/2009SE
K073135Synthes (USA) Hybrid External Fixator ModificationsLXT · Traditional Synthes (Usa)01/29/2008SE
K063832Synthes (USA) Elbow Hinge FixatorLXT · Traditional Synthes (Usa)03/07/2007SE
K060864Multidirectional Threaded PegLXT · Special Hand Innovations, LLC04/28/2006SE
K060403Pta (Progressive Tibial Alignment)LXT · Traditional Meridian Medical03/28/2006SE
K060290Shoulder Fixation SystemLXT · Special Hand Innovations, LLC02/27/2006SE

More from Hand Innovations, LLC

510(k)DeviceDecision
K073331Dvo Extended Articulation Humeral HeadsHSD · Traditional 02/19/2008SE
K060988Total and Hemi Shoulder SystemKWS · Traditional 12/06/2006SE
K052150Volar Plate SystemHRS · Abbreviated 09/08/2005SE

Questions and answers

When was Wrist Fusion Plate cleared by the FDA?

Wrist Fusion Plate (K052754) received a 510(k) decision of Substantially Equivalent on October 27, 2005, 27 days after the submission was received.

What is the product code of K052754?

The FDA product code is LXT – Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite, a Class II (moderate risk) device regulated under 21 CFR 888.3030.