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 Trans1 with 14 510(k) clearances. The most recent is a 510(k) clearance dated Nov 20, 2019: TranS1 AxiaLIF Plus System.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Nov 20, 2019 | TranS1 AxiaLIF Plus SystemK192792 · KWQ | 510(k) clearances |
| Sep 25, 2019 | TranS1 Interbody Fusion SystemK191791 · MAX | 510(k) clearances |
| Apr 1, 2013 | TRANS1LATERAL INTERBODY FUSION SYSTEMK123997 · MAX | 510(k) clearances |
| Aug 23, 2012 | TRANS1 INTERBODY FUSION SYSTEMK120991 · MAX | 510(k) clearances |
| Mar 14, 2011 | TRANS1 AXIALIF PLUSK102334 · KWQ | 510(k) clearances |
| Aug 26, 2010 | TRANS1 LATERAL INTERVERTEBRAL FUSION DEVICE, TK100210 · MAX | 510(k) clearances |
| Jan 21, 2010 | AXIALIF 2L, AXIALIF 2-LEVEL SYSTEM, AXIALIF APOLLO, AXIALIF IIK092124 · KWQ | 510(k) clearances |
| Apr 28, 2008 | TRANS1 AXIALIF 2-LEVEL OR II SYSTEMK073643 · KWQ | 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
