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.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Theken Surgical LLC with 9 510(k) clearances. The most recent is a 510(k) clearance dated May 17, 2005: THEKEN REVEAL VBR SYSTEM.
| May 17, 2005 | THEKEN REVEAL VBR SYSTEMK050058 · MQP | 510(k) clearances |
| Sep 16, 2004 | CORAL SPINAL SYSTEMK041592 · KWP | 510(k) clearances |
| Feb 20, 2004 | THEKEN CPOD/LPOD VERTEBRAL BODY REPLACEMENT SYSTEMK032064 · MQP | 510(k) clearances |
| Oct 29, 2001 | THEKEN LARGE CEMENT RESTRICTORK012462 · JDK | 510(k) clearances |
| Oct 17, 2001 | THEKEN SMALL CEMENT RESTRICTORK012278 · JDK | 510(k) clearances |
| May 16, 2001 | TETHER ACFSK010466 · KWQ | 510(k) clearances |
| Mar 10, 2000 | NONLINEAR TAPER LAG SCREWK994382 · HWC | 510(k) clearances |
| Feb 4, 2000 | DOGBONE ACFSK994383 · KWQ | 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
