Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 3 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Custom Spine, Inc. with 14 510(k) clearances and 1 device recall. The most recent is a 510(k) clearance dated Jul 22, 2015: PATHWAY ELIF.
| Date | Record | Source |
|---|---|---|
| Jul 22, 2015 | PATHWAY ELIFK143143 · MAX | 510(k) clearances |
| Apr 11, 2014 | PROPOSED OPTIMUSK132596 · OVD | 510(k) clearances |
| May 3, 2013 | KOMPREDAK120597 · MRW | 510(k) clearances |
| Mar 28, 2013 | Custom Spine ISSYS LP Inverted Screw System. 8.5MM X 45 MM ISSYS LP Screw Rx Non-Sterile. Custom Spine, Inc. 9 Campus Dr. Parsippany, NJ Class II · On March 28, 2013, Custom Spine, Inc. issued a minor removal of a lot of 18 screws that were found to be out of specific | Device recalls |
| Feb 6, 2012 | PATHWAY AVIDK111726 · MAX | 510(k) clearances |
| Jul 20, 2011 | PATHWAY MODEL 07XXXXK111774 · MAX | 510(k) clearances |
| May 5, 2011 | ISSYS LP SPINAL FIXATION SYSTEMK111099 · NKB | 510(k) clearances |
| May 19, 2010 | REGENT ANTERIOR CERVICAL PLATEK101151 · KWQ | 510(k) clearances |
| Dec 22, 2009 | PATHWAY IVB/VBRK092904 · ODP | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
