WASHINGTON — The Food and Drug Administration said Friday that more than 300 spinal surgical instruments recalled last week by Zimmer Holdings Inc. could potentially cause serious injury or death. Zimmer announced Dec. 20 it was recalling 315 Peek Ardis Inserters after reports that the devices could cause surgical delays and injury when used with […]
FDA
Precision Spine™ Announces FDA 510(k) Clearance for its Minimally Invasive Access System
PARSIPPANY, N.J.–(BUSINESS WIRE)–Precision Spine announced today that it received 510(k) clearance from the FDA on November 20, 2012 for its Mini-Max Minimally Invasive Access System.“The development of the Mini-Max Minimally Invasive Access System represents what we believe to be the next evolutionary step in the ongoing advancement of MIS spine procedures. I believe that the […]
Integra LifeSciences Receives FDA Clearance for Expanded Indication for Spinal Device
PLAINSBORO, N.J., Oct. 9, 2012 (GLOBE NEWSWIRE) — Integra® LifeSciences Holdings Corporation (Nasdaq:IART) today announced that the Food and Drug Administration (FDA) has approved an expanded indication for use of the Integra® Vu aPOD™ Prime Intervertebral Body Fusion Device (IBD) in anterior lumbar interbody fusion (ALIF) procedures. The new stand-alone indication includes four points of […]