Lanx, Inc.
FDA Regulatory Profile
Lanx, Inc. appears in FDA public data with 1 recall, 36 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0400-2014, Class II) was initiated on November 4, 2013. Its most recent 510(k) clearance was granted on July 12, 2013.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 36
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-0400-2014 | Class II | LANX Timberline MPF Lateral Modular Plate Fixation System Straight Split Tip Driver - Short ("Driver | November 4, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K131547 | LANX FUSION SYSTEM | July 12, 2013 |
| K131156 | LANX SPINAL FIXATION SYSTEM | May 24, 2013 |
| K123767 | LANX FUSION SYSTEM- SA | March 18, 2013 |
| K121316 | LANX SPINAL FIZATION SYSTEM | September 10, 2012 |
| K122145 | LANX SPINAL FIXATION SYSTEM | August 17, 2012 |
| K121940 | LANX SPINAL FIXATION SYSTEM | August 2, 2012 |
| K120399 | LANX SPINAL FIXATION SYSTEM | March 9, 2012 |
| K113434 | LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS) | December 19, 2011 |
| K112388 | LANX CERVICAL SA | December 16, 2011 |
| K103091 | LANX SPINAL FIXATION SYSTEM | April 15, 2011 |
| K103237 | LANX SPINAL SYSTEM | March 25, 2011 |
| K103666 | LANX LATERAL | March 23, 2011 |
| K103660 | LANX CERVICAL INTERVERTEBRAL BODY FUSION SYSTEM | February 28, 2011 |
| K102738 | LANX FUSION SYSTEM | February 10, 2011 |
| K103040 | LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS) | February 8, 2011 |
| K100888 | MODIFICATION TO LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM | November 15, 2010 |
| K101364 | LANX FACET SCREW SYSTEM | August 16, 2010 |
| K100935 | LANX SPINAL FIXATION SYSTEM | August 6, 2010 |
| K100191 | LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS) | April 15, 2010 |
| K092765 | LANX ANTERIOR PLATING SYSTEM | April 7, 2010 |