510(k) K141290

HELICAL RIDGE PEEK INTERFERENCE SCREW by MedShape, Inc. — Product Code HWC

K141290 is an FDA 510(k) premarket notification submitted by MedShape, Inc. for the device "HELICAL RIDGE PEEK INTERFERENCE SCREW". The FDA issued a decision of Substantially Equivalent on September 29, 2014. The device falls under product code HWC (Screw, Fixation, Bone), a Class II device regulated under 21 CFR 888.3040. MedShape, Inc. has at least 10 other 510(k) clearances on record.