510(k) K240846

CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments; CarboClear® Hybrid Fenestrated Pedicle Screw System and High V+® Bone Cement; CarboClear® X Fenestrated Pedicle Screw System and High V+® Bone Cement by CarboFix Orthopedics , Ltd. — Product Code NKB

K240846 is an FDA 510(k) premarket notification submitted by CarboFix Orthopedics , Ltd. for the device "CarboClear® Hybrid Pedicle Screw System; CarboClear® Hybrid Navigated Instruments; CarboClear® Hybrid Fenestrated Pedicle Screw System and High V+® Bone Cement; CarboClear® X Fenestrated Pedicle Screw System and High V+® Bone Cement". The FDA issued a decision of Substantially Equivalent on April 25, 2024. The device falls under product code NKB (Thoracolumbosacral Pedicle Screw System), a Class II device regulated under 21 CFR 888.3070. CarboFix Orthopedics , Ltd. has at least 10 other 510(k) clearances on record.