510(k) K092047

ASCENSION METAL GREAT TOE SYSTEM by Ascension Orthopedics, Inc. — Product Code KWD

K092047 is an FDA 510(k) premarket notification submitted by Ascension Orthopedics, Inc. for the device "ASCENSION METAL GREAT TOE SYSTEM". The FDA issued a decision of Substantially Equivalent on January 14, 2010. The device falls under product code KWD (Prosthesis, Toe, Hemi-, Phalangeal), a Class II device regulated under 21 CFR 888.3730. Ascension Orthopedics, Inc. has at least 10 other 510(k) clearances on record.