510(k) K946258

MODEL 8000 ATLAS C-1 ORTHOGONAL ADJUSTING INSTRUMENT by Spinalight, Inc. — Product Code LXM

K946258 is an FDA 510(k) premarket notification submitted by Spinalight, Inc. for the device "MODEL 8000 ATLAS C-1 ORTHOGONAL ADJUSTING INSTRUMENT". The FDA issued a decision of Substantially Equivalent on November 20, 1995. The device falls under product code LXM (Manipulator, Plunger-Like Joint), a Class U device. Spinalight, Inc. has at least 6 other 510(k) clearances on record.