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Sintea Biotech, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
10
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K082679LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.XApril 7, 2009
K081631SINTEA BIOTECH PLS MULTI-AXIAL SCREWSJuly 18, 2008
K072198X-VOID, SPIDERJune 6, 2008
K070181SINTEA BIOTECH DSC/ALF SPINAL SYSTEM, DSC.XX.T5.XX, ALF.XX.T5.XXApril 18, 2007
K060513SINTEA BIOTECH PLS MULTI-AXIAL SCREWS, MODEL PLS.XX.T5.XMarch 10, 2006
K043355SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM WITH POLYAXIAL AND RECOVERY SCREWS, MODEL PLS.01.T5.XDecember 17, 2004
K041989SINTEA BIOTECH ANTERIOR PLATE SYSTEM, MODEL ACP.XX.T5.XSeptember 16, 2004
K031154SINTEA BIOTECH SCHANZ SCREW, MODEL TFX.SS.XX.XJune 24, 2003
K020085SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM, MODEL PLS 00.T5.XDecember 10, 2002
K022065SINTEA BIOTECH TRAUMAFIX SYSTEM, MODEL TFX.00.00.XAugust 6, 2002