510(k) K946165

CMF-TITANIUM CRANIO-MAXILLO-FACIAL FRACTURE FIXATION (OSTEOSYNTHESIS) SYSTEM by Elekta Instruments, Inc. — Product Code HRS

K946165 is an FDA 510(k) premarket notification submitted by Elekta Instruments, Inc. for the device "CMF-TITANIUM CRANIO-MAXILLO-FACIAL FRACTURE FIXATION (OSTEOSYNTHESIS) SYSTEM". The FDA issued a decision of Substantially Equivalent on May 23, 1995. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Elekta Instruments, Inc. has at least 7 other 510(k) clearances on record.