510(k) K070007

SPI ELEMENT PLATFORM O 4.0 MM by Thommen Medical AG — Product Code DZE

K070007 is an FDA 510(k) premarket notification submitted by Thommen Medical AG for the device "SPI ELEMENT PLATFORM O 4.0 MM". The FDA issued a decision of Substantially Equivalent on January 10, 2007. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Thommen Medical AG has at least 10 other 510(k) clearances on record.