510(k) K190482

IGNITE Bone Void Filler by Wrightmedicaltechnologyinc — Product Code MQV

K190482 is an FDA 510(k) premarket notification submitted by Wrightmedicaltechnologyinc for the device "IGNITE Bone Void Filler". The FDA issued a decision of Substantially Equivalent on May 28, 2019. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. Wrightmedicaltechnologyinc has at least 10 other 510(k) clearances on record.