510(k) K965111

STABILIZER SOFT TISSUE ANCHOR MODEL NUMBER TA1005, TA1008, ANCHOR INSERTER/SUTURE ORGANIZER MODEL NUMBERS AI1005, AI1008 by R. Thomas Grotz, M.D., Inc. — Product Code MBI

K965111 is an FDA 510(k) premarket notification submitted by R. Thomas Grotz, M.D., Inc. for the device "STABILIZER SOFT TISSUE ANCHOR MODEL NUMBER TA1005, TA1008, ANCHOR INSERTER/SUTURE ORGANIZER MODEL NUMBERS AI1005, AI1008". The FDA issued a decision of Substantially Equivalent on February 18, 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.