Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Coalign Innovations, Inc. with 9 510(k) clearances. The most recent is a 510(k) clearance dated Sep 12, 2013: ACCULIF TL AND PL CAGE.
| Sep 12, 2013 | ACCULIF TL AND PL CAGEK132505 · MAX | 510(k) clearances |
| Jun 19, 2013 | COALIGN INNOVATIONS ACCULIF XL IBF CAGEK131443 · MAX | 510(k) clearances |
| Apr 3, 2013 | ACCULIF XL CAGEK130194 · MAX | 510(k) clearances |
| Jan 23, 2013 | ACCULIF TL-PEEK CAGEK123281 · MAX | 510(k) clearances |
| Jan 14, 2013 | ACCULIF TL AND PL CAGEK123752 · MAX | 510(k) clearances |
| Jul 5, 2012 | ACCULIF TL CAGEK121683 · MAX | 510(k) clearances |
| Dec 12, 2011 | ACCULIF TL CAGEK113465 · MAX | 510(k) clearances |
| Dec 1, 2011 | ACCULIF TL-PEEK IBF CAGEK112095 · MAX | 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
