510(k) K121725

PIONEER POSTERIOR OCCIPITO-CERVICO-THORACIC (OCT) SYSTEM by Pioneer Surgical Technology, Inc. — Product Code KWP

K121725 is an FDA 510(k) premarket notification submitted by Pioneer Surgical Technology, Inc. for the device "PIONEER POSTERIOR OCCIPITO-CERVICO-THORACIC (OCT) SYSTEM". The FDA issued a decision of Substantially Equivalent on November 7, 2012. The device falls under product code KWP (Appliance, Fixation, Spinal Interlaminal), a Class II device regulated under 21 CFR 888.3050. Pioneer Surgical Technology, Inc. has at least 10 other 510(k) clearances on record.