510(k) K170679

CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems by Medtronic Sofamor Danek — Product Code NKB

K170679 is an FDA 510(k) premarket notification submitted by Medtronic Sofamor Danek for the device "CD HORIZON® Spinal System, Medtronic Reusable Instruments for Use with the IPC® POWEREASE® System, Medtronic Navigated Reusable Instruments for Use with the STEALTHSTATION® and IPC® POWEREASE® Systems". The FDA issued a decision of Substantially Equivalent on May 11, 2017. The device falls under product code NKB (Thoracolumbosacral Pedicle Screw System), a Class II device regulated under 21 CFR 888.3070. Medtronic Sofamor Danek has at least 10 other 510(k) clearances on record.