510(k) K150254

Streamline OCT Occipito-Cervico-Thoracic System by Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) — Product Code KWP

K150254 is an FDA 510(k) premarket notification submitted by Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) for the device "Streamline OCT Occipito-Cervico-Thoracic System". The FDA issued a decision of Substantially Equivalent on April 28, 2015. 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. (Dba Rti Surgical, Inc.) has at least 8 other 510(k) clearances on record.