Ellipse Technologies, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 13
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
| K160325 | PRECICE Intramedullary Limb Lengthening System | April 4, 2016 |
| K141278 | MAGEC SPINAL BRACING AND DISTRACTION SYSTEM | March 24, 2015 |
| K141739 | RESIDUAL LIMB LENGTHENING SYSTEM | October 7, 2014 |
| K140613 | MAGEC SPINAL BRACING AND DISTRACTION SYSTEM | September 18, 2014 |
| K141447 | PRECICE TRAUMA NAIL SYSTEM | June 30, 2014 |
| K141023 | PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM | May 20, 2014 |
| K140178 | ELLIPSE MAGEC SPINAL BRACING AND DISTRACTION SYSTEM | February 27, 2014 |
| K131490 | ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM | January 23, 2014 |
| K133289 | PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM | December 9, 2013 |
| K131677 | PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM | October 11, 2013 |
| K113219 | ELLIPSE PRECICE INTRAMEDULLARY LIMB LENGTHENING SYSTEM | October 19, 2012 |
| K113695 | ELLIPSE PRECICE TRAUMA NAIL SYSTEM | March 28, 2012 |
| K101997 | ELLIPSE INTRAMEDULLARY LIMB LENGTHENING SYSTEM | July 12, 2011 |