510(k) K083469

METASURG CANNULATED TIATANIUM HEMI IMPLANT, MODEL HM-1000 by Metasurg — Product Code KWD

K083469 is an FDA 510(k) premarket notification submitted by Metasurg for the device "METASURG CANNULATED TIATANIUM HEMI IMPLANT, MODEL HM-1000". The FDA issued a decision of Substantially Equivalent on February 13, 2009. The device falls under product code KWD (Prosthesis, Toe, Hemi-, Phalangeal), a Class II device regulated under 21 CFR 888.3730. Metasurg has at least 4 other 510(k) clearances on record.