510(k) K102743

ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES by Ortho Solutions Limited — Product Code HWE

K102743 is an FDA 510(k) premarket notification submitted by Ortho Solutions Limited for the device "ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRES". The FDA issued a decision of Substantially Equivalent on January 20, 2011. The device falls under product code HWE (Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment), a Class I device regulated under 21 CFR 878.4820. Ortho Solutions Limited has at least 5 other 510(k) clearances on record.