510(k) K043355

SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM WITH POLYAXIAL AND RECOVERY SCREWS, MODEL PLS.01.T5.X by Sintea Biotech, Inc. — Product Code KWP

K043355 is an FDA 510(k) premarket notification submitted by Sintea Biotech, Inc. for the device "SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM WITH POLYAXIAL AND RECOVERY SCREWS, MODEL PLS.01.T5.X". The FDA issued a decision of Substantially Equivalent on December 17, 2004. The device falls under product code KWP (Appliance, Fixation, Spinal Interlaminal), a Class II device regulated under 21 CFR 888.3050. Sintea Biotech, Inc. has at least 9 other 510(k) clearances on record.