510(k) K111471

EXOSHAPE (TM) INTERFERENCE FIXATION DEVICE MODEL 1100-00-XXXX (VARIES BY SIZE) by Medshape Solutions, Inc. — Product Code MBI

K111471 is an FDA 510(k) premarket notification submitted by Medshape Solutions, Inc. for the device "EXOSHAPE (TM) INTERFERENCE FIXATION DEVICE MODEL 1100-00-XXXX (VARIES BY SIZE)". The FDA issued a decision of Substantially Equivalent on June 10, 2011. The device falls under product code MBI (Fastener, Fixation, Nondegradable, Soft Tissue), a Class II device regulated under 21 CFR 888.3040. Medshape Solutions, Inc. has at least 5 other 510(k) clearances on record.