M6 Artificial Disc Fda Approval :: pmhub.net

06/02/2019 · This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness Data SSED and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval. Product Name: M6-C™ Artificial Cervical Disc. M6-C artificial cervical disc. The US Food and Drug Administration FDA has approved the M6-C artificial cervical disc Orthofix Medical for patients suffering from cervical disc degeneration. The artificial disc was developed by Spinal Kinetics, a company acquired by Orthofix in April 2018.

M6-L FDA Approved: NO FDA Indication. The M6-L manufacturer has not indicated that they intend to bring the device to the US market. Summary. The M6-L artificial lumbar disc from Orthofix offers a sleek design that’s based on the feel and function of natural spinal discs. 07/02/2019 · Orthofix Medical Inc. OFIX, a global medical device company focused on musculoskeletal products and therapies, today announced U.S. Food and Drug Administration FDA approval of the M6-C™ artificial cervical disc for patients suffering from cervical disc degeneration. The M6-C artificial.

The M6-C™ Artificial Cervical Disc has been marketed outside of the United States since200 6. The M6-C™ Artificial Cervical Disc has not been withdrawn from distribution/ marketing in any country for any safety or effectiveness reasons. The M6-C™ Artificial Cervical Disc has been. “With the approval of the M6-C artificial cervical disc, Orthofix now has the industry’s most comprehensive portfolio of cervical spine products to best serve our surgeon customers and patients,” said Orthofix President and Chief Executive Officer, Brad Mason. 3. When will the M6-L Artificial Lumbar Disc be approved in the US? The M6-L Artificial Lumbar disc is not FDA approved for sale in the US at this time. Currently there are no plans by Spinal Kinetics to initiate an FDA submission or US clinical trial for approval of the M6-L in the US. 4.

Status: This trial has been completed. Introduction DISC is one of 12 sites in US, only in AZ where patients have access to the M6-C Artificial Disc: FDA IDE Pivotal Study. If you are a patient who is interested in participating in this study, please contact DISC directly. Study Objective The primary objective is to []. My name is b6. I have two spinal kinetics m6 artificial discs implanted in my cervical spine. I want to report that one or both have broken. I am aware that there are clinical trials going on in the u. S. At this time, i am not a participant in any of those trials. My implants were done at.

07/02/2019 · LEWISVILLE, Texas--BUSINESS WIRE--Orthofix Medical Inc. NASDAQ:OFIX, a global medical device company focused on musculoskeletal products and therapies, today announced U.S. Food and Drug Administration FDA approval of the M6-C ™ artificial cervical disc for patients suffering from cervical. You can get disc replacement in the US, but there are several limitations. The first set of limitations come from the FDA. Since the studies were typically only done on patients with one bad disc the FDA has for the most part limited use of disc replacement in the USA to one disc surgeries.

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