510(k) K970258

FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHSIS OF UNSTABLE FEMORAL NECK FRACTURES by Ferguson Medical — Product Code HRS

K970258 is an FDA 510(k) premarket notification submitted by Ferguson Medical for the device "FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHSIS OF UNSTABLE FEMORAL NECK FRACTURES". The FDA issued a decision of Substantially Equivalent on May 22, 1997. The device falls under product code HRS (Plate, Fixation, Bone), a Class II device regulated under 21 CFR 888.3030. Ferguson Medical has at least 10 other 510(k) clearances on record.