510(k) K931155

STAPLE, FIXATION BONE; SCREW FIXATION BONE by Roseburg SA — Product Code HWC

K931155 is an FDA 510(k) premarket notification submitted by Roseburg SA for the device "STAPLE, FIXATION BONE; SCREW FIXATION BONE". The FDA issued a decision of Substantially Equivalent on September 1, 1994. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Roseburg SA has at least 10 other 510(k) clearances on record.