SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement

About This 510(k) Submission

K211238 is an FDA 510(k) clearance for the SpineJack Expansion Kit, Vertaplex Radiopaque Bone Cement, Vertaplex HV Radiopaque Bone Cement, a Cement, Bone, Vertebroplasty (Class II — Special Controls, product code NDN), submitted by Stryker Instruments (Kalamazoo, US). The FDA issued a Cleared decision on June 25, 2021, 60 days after receiving the submission on April 26, 2021. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3027.