510(k) K964927

STABILIZER SOFT TISSUE ANCHOR, 8MM MODEL TA1008, ANCHOR INSERTER/SUTURE ORGANIZER, 8MM MODEL AI1008, STABILIZER DRILL, 8 by R. Thomas Grotz, M.D., Inc. — Product Code MBI

K964927 is an FDA 510(k) premarket notification submitted by R. Thomas Grotz, M.D., Inc. for the device "STABILIZER SOFT TISSUE ANCHOR, 8MM MODEL TA1008, ANCHOR INSERTER/SUTURE ORGANIZER, 8MM MODEL AI1008, STABILIZER DRILL, 8". The FDA issued a decision of Substantially Equivalent on February 7, 1997. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. R. Thomas Grotz, M.D., Inc. has at least 3 other 510(k) clearances on record.