Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Zimmer BiometLabelled by claude-sonnet-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 15, 2026, FDA's public records list Spinal Concepts with 33 510(k) clearances. The most recent is a 510(k) clearance dated May 19, 2005: FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICE.
| May 19, 2005 | FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICEK051000 · MQP | 510(k) clearances |
| Apr 15, 2005 | HARMONY PORT SYSTEM, MODEL 1907 SERIESK050706 · GZT | 510(k) clearances |
| Jul 1, 2004 | SPINAL CONCEPTS, INC. TANDEM SPINOUS PROCESS PLATE SYSTEMK040096 · KWP | 510(k) clearances |
| May 27, 2004 | SPINAL CONCEPTS INC. CODAK033663 · MQP | 510(k) clearances |
| Feb 18, 2004 | SPINAL CONCEPTS INC. CADENCE AND TRAXISK033517 · MQP | 510(k) clearances |
| Sep 17, 2003 | SPINAL CONCEPTS, INC. INSIGHT PEDICLE SCREW SYSTEMK031855 · KWQ | 510(k) clearances |
| Sep 11, 2003 | SPINAL CONCEPTS INC. NEX-LINK SPINAL FIXATION SYSTEMK031985 · MNI | 510(k) clearances |
| Aug 22, 2003 | TRAXIS CEMENT RESTRICTORK031318 · JDK | 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
