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Press Release <\/a><\/p>\nNovember 9, 2012<\/h1>\n
Health Canada Medical Device Licence: Medical Designs, LLC receives Medical Device Licence 90081 for the Asfora Bullet Cage System. 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: Medical Designs, LLC receives 510(k) Clearance K121148 from the U.S. Food and Drug Administration for the SAMBASCREW™ System. 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. Medical Designs, LLC is growing and has moved to a new location at 6709 S. Minnesota Ave., Suite 204, Sioux Falls, SD 57108<\/p>\n ISO 13485 Registered: Medical Designs, LLC receives ISO 13485: 2003 Certificate of Registration. Press Release: Spinal Implant Developed by Sanford Clinic Neurosurgeon Receives FDA 510(k) Market Clearance as a Lumbar Intervertebral Body Fusion Device. 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. 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.<\/p>\n","protected":false},"excerpt":{"rendered":" News November 21, 2018 510(k) Clearance:\u00a0 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:\u00a0 Medical Designs, LLC receives 510(k) Clearance K181591 from the U.S. Food … Continue reading
\n Licence <\/a><\/p>\nOctober 15, 2012<\/h1>\n
\n 510(k) Clearance Letter <\/a><\/p>\nAugust 20, 2012<\/h1>\n
\n 510(k) Clearance Letter <\/a><\/p>\nMarch 13, 2012<\/h1>\n
\n 510(k) Clearance Letter <\/a><\/p>\nNovember 1, 2011<\/h1>\n
March 9, 2011<\/h1>\n
\n ISO Certificate <\/a><\/p>\nAugust 26, 2009<\/h1>\n
\n Press Release <\/a><\/p>\nAugust 14, 2009<\/h1>\n
\n 510(k) Clearance Letter <\/a><\/p>\nJuly 2007<\/h1>\n