Medical Device Manufacturer · US , Miami Beach , FL

Sintea Biotech, Inc. - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 2002

10

Total

10

Cleared

0

Denied

FDA 510(k) Regulatory Record - Sintea Biotech, Inc. Orthopedic ✕

10 devices

1-10 of 10

Cleared Apr 07, 2009

LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X

Orthopedic · 204d

Cleared Jul 18, 2008

SINTEA BIOTECH PLS MULTI-AXIAL SCREWS

Orthopedic · 37d

Cleared Jun 06, 2008

Orthopedic · 304d

Cleared Apr 18, 2007

SINTEA BIOTECH DSC/ALF SPINAL SYSTEM, DSC.XX.T5.XX, ALF.XX.T5.XX

Orthopedic · 89d

Cleared Mar 10, 2006

SINTEA BIOTECH PLS MULTI-AXIAL SCREWS, MODEL PLS.XX.T5.X

Orthopedic · 11d

Cleared Dec 17, 2004

SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM WITH POLYAXIAL AND RECOVERY SCREWS,...

Orthopedic · 11d

Cleared Sep 16, 2004

SINTEA BIOTECH ANTERIOR PLATE SYSTEM, MODEL ACP.XX.T5.X

Orthopedic · 55d

Cleared Jun 24, 2003

SINTEA BIOTECH SCHANZ SCREW, MODEL TFX.SS.XX.X

Orthopedic · 74d

Cleared Dec 10, 2002

SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM, MODEL PLS 00.T5.X

Orthopedic · 334d

Cleared Aug 06, 2002

SINTEA BIOTECH TRAUMAFIX SYSTEM, MODEL TFX.00.00.X

Orthopedic · 42d