Distal Volar Radius Plating Systems
FDA 510(k) K112345 · Medos International SARL
510(k) numberK112345
Submission
- Device name
- Distal Volar Radius Plating Systems
- Applicant
- Medos International SARL
Warsaw, IN, US - Received
- August 15, 2011
- Decision date
- October 31, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
| 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 |
| K052754 | Wrist Fusion PlateLXT · Traditional | Dvo Extremity Solutions, LLC | 10/27/2005SE |
More from Dvo Extremity Solutions, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K254157 | CROSSNAV Navigation Enabled Instruments for Disc Preparation and InterbodyOLO · Traditional | 05/26/2026SE |
| K260240 | SYMPHONY Navigation Ready InstrumentsOLO · Traditional | 03/27/2026SE |
| K253249 | TriALTIS Spine SystemNKB · Special | 10/21/2025SE |
| K243249 | TriALTIS Spine SystemNKB · Traditional | 01/17/2025SE |
| K241893 | CROSSNAV Navigation Enabled Instruments and UNAS Navigation ArraysOLO · Traditional | 09/16/2024SE |
| K242042 | TriALTIS Spine SystemNKB · Traditional | 09/09/2024SE |
| K233684 | TriALTIS Spine SystemNKB · Special | 12/12/2023SE |
| K233366 | SYMPHONY OCT SystemNKG · Special | 11/09/2023SE |
| K232492 | 2.7 mm GRYPHON Flex Knotless PEEK Anchor; 2.7 mm GRYPHON Flex Knotless Biocomposite…MBI · Traditional | 10/06/2023SE |
| K231479 | TriALTIS Spine SystemNKB · Traditional | 09/22/2023SE |
Questions and answers
When was Distal Volar Radius Plating Systems cleared by the FDA?
Distal Volar Radius Plating Systems (K112345) received a 510(k) decision of Substantially Equivalent on October 31, 2011, 77 days after the submission was received.
What is the product code of K112345?
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.