510(k) K110895

ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS by Ortho Solutions Limited — Product Code HWC

K110895 is an FDA 510(k) premarket notification submitted by Ortho Solutions Limited for the device "ORTHO SOLUTIONS TRAUMA IMPLANTS FOR OSTEOSYNTHESIS". The FDA issued a decision of Substantially Equivalent on December 19, 2011. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. Ortho Solutions Limited has at least 5 other 510(k) clearances on record.