510(k) K233640

Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS Interbody System; Transcend SPS Interbody System;Transcend NanoTec SPS Interbody System by Alphatec Spine, Inc. — Product Code KWQ

K233640 is an FDA 510(k) premarket notification submitted by Alphatec Spine, Inc. for the device "Segmental Plating System (SPS);IdentiTi SPS Interbody System;IdentiTi NanoTec SPS Interbody System; Transcend SPS Interbody System;Transcend NanoTec SPS Interbody System". The FDA issued a decision of Substantially Equivalent on Feb 22, 2024. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Alphatec Spine, Inc. has at least 10 other 510(k) clearances on record.