510(k) K914858

ACE OPEN-BACK HALO RING by Ace Medical Co. — Product Code JEC

K914858 is an FDA 510(k) premarket notification submitted by Ace Medical Co. for the device "ACE OPEN-BACK HALO RING". The FDA issued a decision of Substantially Equivalent on November 21, 1991. The device falls under product code JEC (Component, Traction, Invasive), a Class II device regulated under 21 CFR 888.3040. Ace Medical Co. has at least 10 other 510(k) clearances on record.