MedShape, Inc. FDA Approvals

0 new drug approvals and 7 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
DynaNail Helix® Fixation System510(k)Sep 23, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Sep 23, 2026
DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro510(k)Mar 18, 2026Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Mar 18, 2026
DynaNail TTC Fusion System510(k)Sep 12, 2025Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Sep 12, 2025
DynaNail Mini Tapered Hybrid510(k)Mar 21, 2024Orthopedic	Orthopedic	510(k)Substantially Equivalent (Special)	Mar 21, 2024
DynaClip® Bone Staple510(k)Aug 19, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Aug 19, 2022
DynaFuse Fixation System510(k)Jan 4, 2022Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jan 4, 2022
Dynanail Mini Hybrid510(k)Jan 15, 2021Orthopedic	Orthopedic	510(k)Substantially Equivalent (Traditional)	Jan 15, 2021