510(k) K161568

Bone Solutions Mixing and Delivery System by Bone Solutions, Inc. — Product Code FMF

K161568 is an FDA 510(k) premarket notification submitted by Bone Solutions, Inc. for the device "Bone Solutions Mixing and Delivery System". The FDA issued a decision of Substantially Equivalent on September 16, 2016. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Bone Solutions, Inc. has at least 7 other 510(k) clearances on record.