Medical device makerLabelled 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 15, 2026, FDA's public records list Paradigm Spine with 16 510(k) clearances. The most recent is a 510(k) clearance dated Jan 27, 2022: Fortilink with TiPlus Technology.
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.
| Jan 27, 2022 | Fortilink with TiPlus TechnologyK213493 · ODP | 510(k) clearances |
| Oct 7, 2020 | Fortilink Cages with TiPlus TechnologyK201453 · MAX | 510(k) clearances |
| Aug 4, 2020 | CoFix SystemK201704 · PEK | 510(k) clearances |
| Sep 8, 2016 | coflex-IFK153302 · PEK | 510(k) clearances |
| May 9, 2012 | DSS STABILIZATION SYSTEM-RIGIDK120491 · MNH | 510(k) clearances |
| Feb 13, 2012 | COFLEX-FK112595 · KWP | 510(k) clearances |
| Jan 10, 2012 | DSS STABILIZATION SYSTEMK113625 · NKB | 510(k) clearances |
| Oct 6, 2010 | PARADIGM INTERSPINOUS FUSION PLATEK093438 · KWP | 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
