Custom Spine, Inc.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 14
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1819-2013 | Class II | Custom Spine ISSYS LP Inverted Screw System. 8.5MM X 45 MM ISSYS LP Screw Rx Non-Sterile. Custom S | March 28, 2013 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|---|---|
| K143143 | PATHWAY ELIF | July 22, 2015 |
| K132596 | PROPOSED OPTIMUS | April 11, 2014 |
| K120597 | KOMPREDA | May 3, 2013 |
| K111726 | PATHWAY AVID | February 6, 2012 |
| K111774 | PATHWAY MODEL 07XXXX | July 20, 2011 |
| K111099 | ISSYS LP SPINAL FIXATION SYSTEM | May 5, 2011 |
| K101151 | REGENT ANTERIOR CERVICAL PLATE | May 19, 2010 |
| K092904 | PATHWAY IVB/VBR | December 22, 2009 |
| K091134 | CUSTOM SPINE REGENT ANTERIOR CERVICAL PLATE | August 17, 2009 |
| K090566 | PATHWAY AVID | June 1, 2009 |
| K080281 | PATHWAY | May 1, 2008 |
| K072866 | ISSYS LP SPINAL FIXATION SYSTEM | December 13, 2007 |
| K070281 | ISSYS LP SPINAL FIXATION SYSTEM | June 11, 2007 |
| K043522 | ISSYS PEDICLE SCREW SYSTEM | January 14, 2005 |