510(k) K183084

Fuji Cervical Plate System by Altus Partners, LLC — Product Code KWQ

K183084 is an FDA 510(k) premarket notification submitted by Altus Partners, LLC for the device "Fuji Cervical Plate System". The FDA issued a decision of Substantially Equivalent on May 29, 2019. The device falls under product code KWQ (Appliance, Fixation, Spinal Intervertebral Body), a Class II device regulated under 21 CFR 888.3060. Altus Partners, LLC has at least 10 other 510(k) clearances on record.