Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in FinlandLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Bionx Implants with 30 510(k) clearances. The most recent is a 510(k) clearance dated Apr 24, 2003: IMPACT SUTURE ANCHOR. MODEL 433510.
| Date | Record | Source |
|---|---|---|
| Apr 24, 2003 | IMPACT SUTURE ANCHOR. MODEL 433510K030388 · HWC | 510(k) clearances |
| Oct 4, 2002 | NUGEN FX SCREWK023022 · HWC | 510(k) clearances |
| Jun 26, 2002 | DUET SUTURE ANCHORK020056 · HWC | 510(k) clearances |
| Feb 22, 2002 | BIOSORBFX O/M 2.0/2/4 SYSTEMK011569 · JEY | 510(k) clearances |
| Nov 21, 2001 | MODIFICATION TO: 1.5 BONE FIXATION KIT, MODELS BXS6114, BXS6214K013546 · HWC | 510(k) clearances |
| Oct 12, 2001 | BIOCUFF,C, MODELS 236018, 236028, 236036K013057 · MAI | 510(k) clearances |
| Sep 19, 2001 | CONTOUR MENISCUS ARROW, MODELS 541110, 541113, AND 541116K012334 · MAI | 510(k) clearances |
| Jul 18, 2001 | 1.5MM BONE FIXATION KITK012000 · HWC | 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
