510(k) K254110

DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro by MedShape, Inc. — Product Code HWC

K254110 is an FDA 510(k) premarket notification submitted by MedShape, Inc. for the device "DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro". The FDA issued a decision of Substantially Equivalent on March 18, 2026. 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.