LXT — Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Class II
FDA product code LXT covers "Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite", a Class II medical device regulated under 21 CFR 888.3030. Submissions are reviewed by the Orthopedic panel. Devices under this code are implants. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LXT
- Device Class
- Class II
- Regulation Number
- 888.3030
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K230067 | new paradigm biomedical | Para-Fix External Fixation System | September 22, 2023 |
| K131636 | acumed | POLARUS CONNECT | October 10, 2013 |
| K132704 | biomet | DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW | October 9, 2013 |
| K112345 | medos international sarl | DISTAL VOLAR RADIUS PLATING SYSTEMS | October 31, 2011 |
| K090374 | depuy orthopaedics | STERILE DVR ANATOMIC PLATES VARIOUS CONFIGURATIONS) MODEL (S) 131212001,2, 5-10 | March 11, 2009 |
| K073135 | synthes (usa) | SYNTHES (USA) HYBRID EXTERNAL FIXATOR MODIFICATIONS | January 29, 2008 |
| K063832 | synthes (usa) | SYNTHES (USA) ELBOW HINGE FIXATOR | March 7, 2007 |
| K060864 | hand innovations | MULTIDIRECTIONAL THREADED PEG | April 28, 2006 |
| K060403 | meridian medical | PTA (PROGRESSIVE TIBIAL ALIGNMENT) | March 28, 2006 |
| K060290 | hand innovations | SHOULDER FIXATION SYSTEM | February 27, 2006 |
| K052754 | dvo extremity solutions | WRIST FUSION PLATE | October 27, 2005 |
| K051728 | hand innovations | MODIFICATION TO SHOULDER FIXATION SYSTEM | July 20, 2005 |
| K051306 | howmedica osteonics | HOFFMANN II MRI EXTERNAL FIXATION SYSTEM | June 17, 2005 |
| K050932 | hand innovations | DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM | April 26, 2005 |
| K050631 | synthes (usa) | SYNTHES (USA) SMALL ADJUSTABLE CLAMP-MR SAFE LINE EXTENSION | April 11, 2005 |
| K042458 | a.m. surgical | A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM | October 7, 2004 |
| K042059 | hand innovations | SHOULDER FIXATION SYSTEM | September 30, 2004 |
| K033805 | synthes (usa) | SYNTHES (USA) 3.5 / 4.5 MM LCP METAPHYSEAL PLATES | February 20, 2004 |
| K033145 | howmedica osteonics | HOFFMANN II PELVIC CLAMP | November 5, 2003 |
| K032705 | hand innovations | DISTAL RADIUS FRACTURE REPAIR SYSTEM | October 1, 2003 |