Distal Volar Radius Anatomical Plate System
FDA 510(k) K050932 · Hand Innovations, Inc.
510(k) numberK050932
Submission
- Device name
- Distal Volar Radius Anatomical Plate System
- Applicant
- Hand Innovations, Inc.
Miami Lakes, FL, US - Received
- April 14, 2005
- Decision date
- April 26, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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
Other 510(k)s with product code LXT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K230067 | Para-Fix External Fixation SystemLXT · Traditional | New Paradigm Biomedical | 09/22/2023SE |
| K131636 | Polarus ConnectLXT · Traditional | Acumed, LLC | 10/10/2013SE |
| K132704 | Distal Radius Volar Rim Plate Standard, Distal Radius Volar Rim Plate NarrowLXT · Traditional | Biomet | 10/09/2013SE |
| K112345 | Distal Volar Radius Plating SystemsLXT · Traditional | Medos International SARL | 10/31/2011SE |
| K090374 | Sterile DVR Anatomic Plates Various Configurations) Model (S) 131212001,2, 5-10 2.5MM…LXT · Special | DePuy Orthopaedics, Inc. | 03/11/2009SE |
| K073135 | Synthes (USA) Hybrid External Fixator ModificationsLXT · Traditional | Synthes (Usa) | 01/29/2008SE |
| K063832 | Synthes (USA) Elbow Hinge FixatorLXT · Traditional | Synthes (Usa) | 03/07/2007SE |
| K060864 | Multidirectional Threaded PegLXT · Special | Hand Innovations, LLC | 04/28/2006SE |
| K060403 | Pta (Progressive Tibial Alignment)LXT · Traditional | Meridian Medical | 03/28/2006SE |
| K060290 | Shoulder Fixation SystemLXT · Special | Hand Innovations, LLC | 02/27/2006SE |
More from Hand Innovations, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K061748 | Fragment Plate SystemKTT · Special | 07/17/2006SE |
| K060864 | Multidirectional Threaded PegLXT · Special | 04/28/2006SE |
| K060294 | Diaphyseal PlateHRS · Traditional | 03/22/2006SE |
| K060290 | Shoulder Fixation SystemLXT · Special | 02/27/2006SE |
| K052294 | Shoulder Nail PlateHRS · Traditional | 10/21/2005SE |
| K052248 | Dorsal Nail Plate, AnatomicalHRS · Special | 09/14/2005SE |
| K051728 | Modification to Shoulder Fixation SystemLXT · Special | 07/20/2005SE |
| K042059 | Shoulder Fixation SystemLXT · Traditional | 09/30/2004SE |
| K041157 | Modification to Small Bone Fixation SystemHTY · Traditional | 07/30/2004SE |
| K041081 | Fragment Plate System, Screws, Pins and K-WiresKTT · Traditional | 07/01/2004SE |
Questions and answers
When was Distal Volar Radius Anatomical Plate System cleared by the FDA?
Distal Volar Radius Anatomical Plate System (K050932) received a 510(k) decision of Substantially Equivalent on April 26, 2005, 12 days after the submission was received.
What is the product code of K050932?
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.