510(k) K930153

SYSTEM III HALO RING by Jerome Medical — Product Code JEC

K930153 is an FDA 510(k) premarket notification submitted by Jerome Medical for the device "SYSTEM III HALO RING". The FDA issued a decision of Substantially Equivalent on August 6, 1993. The device falls under product code JEC (Component, Traction, Invasive), a Class II device regulated under 21 CFR 888.3040. Jerome Medical has at least 8 other 510(k) clearances on record.