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 Integra LifeSciencesLabelled 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 Theken Spine with 23 510(k) clearances. The most recent is a 510(k) clearance dated Aug 28, 2012: INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERY.
| Aug 28, 2012 | INSTRUMENT SYSTEM FOR ENDOSCOPIC SPINAL SURGERYK121482 · HRX | 510(k) clearances |
| Jun 27, 2012 | VU APOD INTERVERTEBRAL BODY FUSION DEVICEK121211 · OVD | 510(k) clearances |
| May 30, 2012 | STAINLESS STEEL SPINAL SYSTEMK120829 · NKB | 510(k) clearances |
| Feb 3, 2012 | CORAL SPINAL SYSTEMK120047 · NKB | 510(k) clearances |
| Aug 2, 2011 | VU C*POD INTERVERTEBRAL BODY FUSION DEVICEK111675 · ODP | 510(k) clearances |
| Jan 5, 2011 | PARAMOUNT R IBF DEVICEK103228 · MAX | 510(k) clearances |
| Dec 16, 2010 | CERVICAL STANDALONE INTERVERTEBRAL BODY FUSION DEVICEK102323 · OVE | 510(k) clearances |
| Sep 2, 2010 | VU APOD INTERVERTEBRAL BODY FUSION DEVICEK101310 · OVD | 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
