Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in SwitzerlandLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of StrykerLabelled 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 14, 2026, FDA's public records list Plus Orthopedics with 43 510(k) clearances. The most recent is a 510(k) clearance dated Aug 1, 2007: CERAMIC BALL HEADS, 28, 32 AND 36 MM.
| Aug 1, 2007 | CERAMIC BALL HEADS, 28, 32 AND 36 MMK070928 · LZO | 510(k) clearances |
| Jul 31, 2007 | PIGALILEO TOTAL HIP REPLACEMENT (THR) SYSTEMK070731 · HAW | 510(k) clearances |
| Apr 16, 2007 | POLARCUP DUAL MOBILITY SYSTEMK070278 · LPH | 510(k) clearances |
| Mar 2, 2007 | PROMOS MODULAR SHOULDER SYSTEMK063578 · HSD | 510(k) clearances |
| Oct 6, 2006 | PIGALILEO TOTAL KNEE REPLACEMENT (TKR) SYSTEMK061362 · HAW | 510(k) clearances |
| Jan 8, 2004 | PROMOS SHOULDERK032126 · HSD | 510(k) clearances |
| Dec 18, 2003 | MODIFICATION TO SLIM GLIDING NAIL SYSTEMK033763 · KTT | 510(k) clearances |
| Sep 23, 2003 | MODULAR PLUS HIP STEMK032709 · LWJ | 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
