Pta (Progressive Tibial Alignment)
FDA 510(k) K060403 · Meridian Medical
510(k) numberK060403
Submission
- Device name
- Pta (Progressive Tibial Alignment)
- Applicant
- Meridian Medical
Irvine, CA, US - Received
- February 15, 2006
- Decision date
- March 28, 2006
- 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 |
| 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 |
| K060290 | Shoulder Fixation SystemLXT · Special | Hand Innovations, LLC | 02/27/2006SE |
| K052754 | Wrist Fusion PlateLXT · Traditional | Dvo Extremity Solutions, LLC | 10/27/2005SE |
Questions and answers
When was Pta (Progressive Tibial Alignment) cleared by the FDA?
Pta (Progressive Tibial Alignment) (K060403) received a 510(k) decision of Substantially Equivalent on March 28, 2006, 41 days after the submission was received.
What is the product code of K060403?
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.