510(k) K912190

STRYKER HIGH VACUUM BONE CEMENT MIXER/INJECT SYST by Stryker Corp. — Product Code JDZ

K912190 is an FDA 510(k) premarket notification submitted by Stryker Corp. for the device "STRYKER HIGH VACUUM BONE CEMENT MIXER/INJECT SYST". The FDA issued a decision of Substantially Equivalent on August 29, 1991. The device falls under product code JDZ (Mixer, Cement, For Clinical Use), a Class I device regulated under 21 CFR 888.4210. Stryker Corp. has at least 10 other 510(k) clearances on record.