510(k) K984200

STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 AND 8MM; STABILIZER DRILL, 5 AND 8MM, NONSTERILE; STABILIZE by R. Thomas Grotz, M.D., Inc. — Product Code MBI

K984200 is an FDA 510(k) premarket notification submitted by R. Thomas Grotz, M.D., Inc. for the device "STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 AND 8MM; STABILIZER DRILL, 5 AND 8MM, NONSTERILE; STABILIZE". The FDA issued a decision of Substantially Equivalent on January 21, 1999. 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.