510(k) K990999

MODIFICATION OF: EBI SPINELINK SYSTEM by Electro-Biology, Inc. — Product Code MAI

K990999 is an FDA 510(k) premarket notification submitted by Electro-Biology, Inc. for the device "MODIFICATION OF: EBI SPINELINK SYSTEM". The FDA issued a decision of Substantially Equivalent on April 14, 1999. The device falls under product code MAI (Fastener, Fixation, Biodegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3030. Electro-Biology, Inc. has at least 10 other 510(k) clearances on record.