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 14, 2026, FDA's public records list Sintea Biotech with 10 510(k) clearances. The most recent is a 510(k) clearance dated Apr 7, 2009: LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X.
| Apr 7, 2009 | LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.XK082679 · JEC | 510(k) clearances |
| Jul 18, 2008 | SINTEA BIOTECH PLS MULTI-AXIAL SCREWSK081631 · MNH | 510(k) clearances |
| Jun 6, 2008 | X-VOID, SPIDERK072198 · HRX | 510(k) clearances |
| Apr 18, 2007 | SINTEA BIOTECH DSC/ALF SPINAL SYSTEM, DSC.XX.T5.XX, ALF.XX.T5.XXK070181 · MQP | 510(k) clearances |
| Mar 10, 2006 | SINTEA BIOTECH PLS MULTI-AXIAL SCREWS, MODEL PLS.XX.T5.XK060513 · KWP | 510(k) clearances |
| Dec 17, 2004 | SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM WITH POLYAXIAL AND RECOVERY SCREWS, MODEL PLS.01.T5.XK043355 · KWP | 510(k) clearances |
| Sep 16, 2004 | SINTEA BIOTECH ANTERIOR PLATE SYSTEM, MODEL ACP.XX.T5.XK041989 · KWQ | 510(k) clearances |
| Jun 24, 2003 | SINTEA BIOTECH SCHANZ SCREW, MODEL TFX.SS.XX.XK031154 · JDW | 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
