FDA 510(k) Applications Submitted by CUSTOM SPINE, INC.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K120597 |
02/28/2012 |
KOMPREDA |
CUSTOM SPINE, INC. |
| K111726 |
06/20/2011 |
PATHWAY AVID |
CUSTOM SPINE, INC. |
| K043522 |
12/20/2004 |
ISSYS PEDICLE SCREW SYSTEM |
CUSTOM SPINE, INC. |
| K132596 |
08/19/2013 |
PROPOSED OPTIMUS |
CUSTOM SPINE, INC. |
| K143143 |
11/03/2014 |
PATHWAY ELIF |
CUSTOM SPINE, INC. |
| K070281 |
01/29/2007 |
ISSYS LP SPINAL FIXATION SYSTEM |
CUSTOM SPINE, INC. |
| K080281 |
02/04/2008 |
PATHWAY |
CUSTOM SPINE, INC. |
| K090566 |
03/03/2009 |
PATHWAY AVID |
CUSTOM SPINE, INC. |
| K091134 |
04/20/2009 |
CUSTOM SPINE REGENT ANTERIOR CERVICAL PLATE |
CUSTOM SPINE, INC. |
| K111099 |
04/20/2011 |
ISSYS LP SPINAL FIXATION SYSTEM |
CUSTOM SPINE, INC. |
| K092904 |
09/21/2009 |
PATHWAY IVB/VBR |
CUSTOM SPINE, INC. |
| K072866 |
10/05/2007 |
ISSYS LP SPINAL FIXATION SYSTEM |
CUSTOM SPINE, INC. |
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