News

July 1, 2015

510(k) Clearance: Medical Designs, LLC receives 510(k) Clearance K143688 from the U.S. Food and Drug Administration for the Asfora Anterior Cervical Plate (AACP) System.

April 17, 2013

Press Release: Medical Designs, LLC Announces the National Marketing Launch of the FDA-Approved SAMBASCREW™ System, a Minimally Invasive Solution for the Treatment of SI-Joint Dysfunction.
Press Release

November 9, 2012

Health Canada Medical Device Licence: Medical Designs, LLC receives Medical Device Licence 90081 for the Asfora Bullet Cage System.
Licence

October 15, 2012

510(k) Clearance: Medical Designs, LLC receives 510(k) Clearance K122497 from the U.S. Food and Drug Administration for the Asfora Anterior Cervical Plate System.
510(k) Clearance Letter

August 20, 2012

510(k) Clearance: Medical Designs, LLC receives 510(k) Clearance K121148 from the U.S. Food and Drug Administration for the SAMBASCREW™ System.
510(k) Clearance Letter

March 13, 2012

510(k) Clearance: Medical Designs, LLC receives Special 510(k) Clearance K112648 from the U.S. Food and Drug Administration for the Asfora Bullet Cage System to include all approaches.
510(k) Clearance Letter

November 1, 2011

Medical Designs, LLC is growing and has moved to a new location at 6709 S. Minnesota Ave., Suite 204, Sioux Falls, SD 57108

March 9, 2011

ISO 13485 Registered: Medical Designs, LLC receives ISO 13485: 2003 Certificate of Registration.
ISO Certificate

August 26, 2009

Press Release: Spinal Implant Developed by Sanford Clinic Neurosurgeon Receives FDA 510(k) Market Clearance as a Lumbar Intervertebral Body Fusion Device.
Press Release

August 14, 2009

510(k) Clearance: Medical Designs, LLC receives 510(k) Clearance K090048 from the U.S. Food and Drug Administration for the Asfora Bullet Cage System.
510(k) Clearance Letter

July 2007

Medical Designs, LLC brought to market the Subdural Evacuating Port System (SEPS). The SEPS is a fast, simple, safe and effective, minimally invasive procedure for draining subdural fluid accumulations such as hygromas and liquid-state subdural hematomas under local anesthesia. The SEPS device was acquired by Medtronic Neurologic in July 2007. For further information regarding this product, please contact Medtronic Neurologic at (800) 468-9710.