Surgical Product Guide » 510(k) clearance

Antibacterial Patch For Soft Tissue Repair

admin — Tue, 28 Sep 2010 10:23:38 +0000

TYRX, Inc. introduces AIGISRx® ST, its antibacterial product for the surgical repair of damaged or ruptured soft tissue. TYRX had previously received 510(k) clearance to market a product for hernia repair and other abdominal soft tissue deficiencies. The new clearance adds the use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue.

Read the full story here

Integra LifeSciences Announces Launch of New Surgical Spine Instruments

admin — Thu, 23 Sep 2010 07:22:36 +0000

Integra LifeSciences Holdings Corporation has announced the introduction of a new line of extended length and “detachable” Ruggles(TM) kerrison rongeurs, which are key instruments used in a variety of neuro and spine surgeries. The Ruggles(TM) kerrison rongeurs with a detachable feature received 510(k) clearance from the United States Food and Drug Administration (FDA). The new feature allows for easier cleaning, and special coatings help preserve the instrument’s sharpness.

Read the full story here

Medyssey Spine Receives FDA 510(k) Clearance For Zenius(TM) Thoracolumbar Spinal System In Titanium Alloy (Ti6AL-4V ELI)

admin — Tue, 31 Aug 2010 08:41:37 +0000

South Korea-based Medyssey Co., Ltd. announced that the Company has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Zenius(TM) Thoracolumbar Spinal System. Though currently available in limited release, Medyssey will launch the new Zenius(TM) System in the United States in Q4. The Zenius(TM) System is a Ti alloy 5.5 mm Rod and Thoracolumbar Pedicle Screw Construct for the surgical treatment of spinal trauma, deformity, and degenerative spinal pathologies.

Read the full story here

FDA clears Covidien Leak Compensation software

admin — Mon, 10 Aug 2009 13:35:14 +0000

Covidien received 510(k) clearance from the FDA to market its Leak Compensation software feature for the Puritan Bennett 840™ ventilator system. This option provides continuous levels of mechanical ventilation to patients requiring respiratory support, regardless of the level of gas leakage that might occur in the circuit or past a patient interface device in the clinical setting.