DistributorLabelled 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 its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Kalitec Direct with 9 510(k) clearances. The most recent is a 510(k) clearance dated Jun 14, 2018: TiWAVE-C™ Porous Titanium Cervical Cage.
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.
| Jun 14, 2018 | TiWAVE-C™ Porous Titanium Cervical CageK180401 · ODP | 510(k) clearances |
| Oct 25, 2017 | CosmoLock Pedicle Screw SystemK172808 · NKB | 510(k) clearances |
| Sep 22, 2017 | Matira™ Anterior Cervical SystemK172086 · KWQ | 510(k) clearances |
| May 9, 2017 | Ocata Anterior Cervical SystemK170342 · KWQ | 510(k) clearances |
| Mar 16, 2017 | Kalitec Direct InSePtion™ MIS Fixation SystemK163471 · PEK | 510(k) clearances |
| Jun 19, 2014 | COSMOLOCK PEDICLE SCREW SYSTEMK140678 · MNH | 510(k) clearances |
| Apr 16, 2014 | INTESS CERVICAL CAGE SYSTEMK133815 · ODP | 510(k) clearances |
| Mar 28, 2013 | INTESS LUMBAR CAGEK123100 · 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
