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 13, 2026, FDA's public records list Phygen with 7 510(k) clearances. The most recent is a 510(k) clearance dated Mar 7, 2012: LEUCADIA 4.5 MM PEDICLE SCREW SYSTEM.
| Date | Record | Source |
|---|---|---|
| Mar 7, 2012 | LEUCADIA 4.5 MM PEDICLE SCREW SYSTEMK120355 · NKB | 510(k) clearances |
| Jan 17, 2012 | LEUCADIA AUTOLOK PEDICLE SCREW SYSTEMK113366 · NKB | 510(k) clearances |
| Nov 2, 2011 | LEUCADIA(TM) MIS PEDICLE SCREW SYSTEMK112931 · NKB | 510(k) clearances |
| Aug 2, 2011 | DEL MAR MONOAXIAL PEDICLE SCREW SYSTEMK110679 · NKB | 510(k) clearances |
| May 25, 2011 | LEUCADIA PEDICLE SCREW SYSTEMK110588 · NKB | 510(k) clearances |
| Mar 2, 2011 | LAGUNA PEDICLE SCREW SYSTEMK103748 · NKB | 510(k) clearances |
| Feb 8, 2011 | LEUCADIA PEDICLE SCREW SYSTEMK103102 · MNI | 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
