510(k) K251965

Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) by Alphatec Spine, Inc. — Product Code KWQ

K251965 is an FDA 510(k) premarket notification submitted by Alphatec Spine, Inc. for the device "Proximity Anterior Cervical Plate System; Segmental Plating System (SPS)". The FDA issued a decision of Substantially Equivalent on August 28, 2025. 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.