510(k) K234092

SafeOp 3: Neural Informatix Systeem by Alphatec Spine, Inc. — Product Code GWF

K234092 is an FDA 510(k) premarket notification submitted by Alphatec Spine, Inc. for the device "SafeOp 3: Neural Informatix Systeem". The FDA issued a decision of Substantially Equivalent on April 19, 2024. The device falls under product code GWF (Stimulator, Electrical, Evoked Response), a Class II device regulated under 21 CFR 882.1870. Alphatec Spine, Inc. has at least 10 other 510(k) clearances on record.