News
November 21, 2018
510(k) Clearance: Medical Designs, LLC receives 510(K) Clearance K182352 from the U.S. Food and Drug Administration for the SP-LINK™ System.
September 26, 2018
510(k) Clearance: Medical Designs, LLC receives 510(k) Clearance K181591 from the U.S. Food and Drug Administration for the Fixated Asfora BULLET CAGE® (FABC) System.
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.