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Medshape, INC.

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
16
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2513-2025Class IIMedshape Universal Joints, REF: DNE-9000-UJJune 2, 2025
Z-0453-2022Class IIDYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, SterileNovember 17, 2021

Recent 510(k) Clearances

K-NumberDeviceDate
K254110DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip QMarch 18, 2026
K250628DynaNail TTC Fusion SystemSeptember 12, 2025
K240530DynaNail Mini Tapered HybridMarch 21, 2024
K220812DynaClip® Bone StapleAugust 19, 2022
K203595DynaFuse Fixation SystemJanuary 4, 2022
K203381Dynanail Mini HybridJanuary 15, 2021
K193305DynaClip Bone StapleApril 23, 2020
K182677DynaNail MiniFebruary 14, 2019
K181781DynaClipTM Bone StapleNovember 5, 2018
K171376DynaNail TTC Fusion SystemNovember 2, 2017
K141420FASTFORWARDDecember 18, 2014
K141290HELICAL RIDGE PEEK INTERFERENCE SCREWSeptember 29, 2014
K132783EXOSHAPE DUO SOFT TISSUE FASTENERDecember 9, 2013
K130467POROUS MORPHIX SUTURE ANCHOR WITH FORCE FIBER SUTUREDecember 5, 2013
K123350ECLIPSE SOFT TISSUE FASTENERMarch 7, 2013
K113828DYNANAIL ANKLE ARTHRODESIS NAILFebruary 29, 2012