FDA approvals

Negative Pressure Surgical Incision Management System

Aatru Medical LLC received U.S. Food and Drug Administration (FDA) 510(k) Class II clearance of its Negative Pressure Surgical Incision Management System (NPSIMS), an innovative mode-of-action that eliminates the expensive electro-mechanical pump, battery, and electronics found in most negative pressure wound therapy (NPWT) systems deployed for closed surgical incision applications. The single-use, disposable NPSIMS is easily activated and operates silently during therapy delivery. A patented pre-assembled dressing provides ease-of-application with exceptional sealing capability while providing patient comfort and ergonometric appeal. https://www.aatru.com

MACH Screw Clip system

Able Medical Devices’ MACH Screw Clip system – a single-use, sterile screw delivery system that doesn’t require reprocessing or sterilization – has been granted 510(k) clearance by the U.S. Food and Drug Administration (FDA). By clipping directly onto the Valkyrie Thoracic Fixation System, the MACH Screw Clip delivers screws extremely fast and accurately for thoracic fixation. The clips are pre-loaded with screws and are available in a modular 2- or 4-screw configuration.

The system also incorporates other technological advantages such as a hard shoulder stop, which prevents overdriving of screws and ensures a flush screw-to-plate interface. The clips can also be loaded with Able Medicals HAnano Bioactive screws that draw osteoblasts up into their threads and accelerate osseointegration. https://www.ablemedicaldevices.com

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