510(k) K211238

SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement by Stryker Instruments — Product Code NDN

K211238 is an FDA 510(k) premarket notification submitted by Stryker Instruments for the device "SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement". The FDA issued a decision of Substantially Equivalent on June 25, 2021. The device falls under product code NDN (Cement, Bone, Vertebroplasty), a Class II device regulated under 21 CFR 888.3027. Stryker Instruments has at least 10 other 510(k) clearances on record.