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 14, 2026, FDA's public records list Scandius Biomedical with 6 510(k) clearances. The most recent is a 510(k) clearance dated Dec 19, 2006: MODIFICATION TO SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEM.
| Dec 19, 2006 | MODIFICATION TO SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEMK063499 · MBI | 510(k) clearances |
| Dec 19, 2006 | MODIFICATION TO SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEMK063497 · MAI | 510(k) clearances |
| Apr 11, 2006 | SCANDIUS TRITIS ABSORBABLE TIBIAL RECONSTRUCTION SYSTEMK060522 · MAI | 510(k) clearances |
| Dec 20, 2005 | SCANDIUS TRITIS TIBIAL ACL RECONSTRUCTION SYSTEMK052810 · MBI | 510(k) clearances |
| Oct 20, 2004 | SCANDIUS ABSORBABLE ACL RECONSTRUCTION SYSTEMK041961 · HWC | 510(k) clearances |
| Sep 8, 2004 | SCANDIUS ACL RECONSTRUCTION SYSTEMK041749 · 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