DynaNail TTC Fusion System

• K Number: K250628
• Device Name: DynaNail TTC Fusion System
• Manufacturer: MedShape, Inc.
• Date Cleared: 2025-09-12 ( 193 days)
• Product Code: HSB
• Regulation Number: 888.3020
• Type: Traditional
• Panel: OR
• Reference & Predicate Devices: N/A

Intended Use

Get notified when PDF is available

Device Description

Get notified when PDF is available

AI/ML Overview

Get notified when PDF is available

Regulation Number and Section

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.