510(k) K232668

Cove Strip, OsteoCove Strip by SeaSpine Orthopedics Corporation — Product Code MQV

K232668 is an FDA 510(k) premarket notification submitted by SeaSpine Orthopedics Corporation for the device "Cove Strip, OsteoCove Strip". The FDA issued a decision of Substantially Equivalent on September 27, 2023. The device falls under product code MQV (Filler, Bone Void, Calcium Compound), a Class II device regulated under 21 CFR 888.3045. SeaSpine Orthopedics Corporation has at least 10 other 510(k) clearances on record.