510(k) K132740

SPINEFRONTIER LESPLASTY POSTERIOR CERVICAL LAMINOPLASTY SYSTEM by Spinefrontier, Inc. — Product Code NQW

K132740 is an FDA 510(k) premarket notification submitted by Spinefrontier, Inc. for the device "SPINEFRONTIER LESPLASTY POSTERIOR CERVICAL LAMINOPLASTY SYSTEM". The FDA issued a decision of Substantially Equivalent on November 26, 2013. The device falls under product code NQW (Orthosis, Spine, Plate, Laminoplasty, Metal), a Class II device regulated under 21 CFR 888.3050. Spinefrontier, Inc. has at least 10 other 510(k) clearances on record.