Medical Device Manufacturer · US , Atlanta , GA

MedShape, Inc. - FDA 510(k) Cleared Devices

17 submissions · 17 cleared · Since 2012

Recent clearances: DynaNail Helix® Fixation System, DynaNail Mini, DynaNail TTC Fusion System

View 17 510(k) Devices ↓

17

Total

17

Cleared

0

Denied

FDA 510(k) Regulatory Record - MedShape, Inc. Orthopedic ✕

17 devices

1-12 of 17

Cleared Sep 23, 2026

DynaNail Helix® Fixation System

Orthopedic · 181d

Cleared Mar 18, 2026

Orthopedic · 89d

Cleared Sep 12, 2025

DynaNail TTC Fusion System

Orthopedic · 193d

Cleared Mar 21, 2024

DynaNail Mini Tapered Hybrid

Orthopedic · 27d

Cleared Aug 19, 2022

DynaClip® Bone Staple

Orthopedic · 151d

Cleared Jan 04, 2022

DynaFuse Fixation System

Orthopedic · 391d

Cleared Jan 15, 2021

Dynanail Mini Hybrid

Orthopedic · 59d

Cleared Apr 23, 2020

DynaClip Bone Staple

Orthopedic · 146d

Cleared Feb 14, 2019

Orthopedic · 141d

Cleared Nov 05, 2018

DynaClipTM Bone Staple

Orthopedic · 125d

Cleared Nov 02, 2017

DynaNail TTC Fusion System

Orthopedic · 176d

Cleared Dec 18, 2014

Orthopedic · 203d