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Application was Submitted on July 19, 2024, Passed the FDA Administrative Review, and is Now Under Substantive Review
FDA Decision is Expected Within 90 Days of Initial Submission; However, the Process May be Paused if Additional Information is Requested
AUSTIN, TX / ACCESSWIRE / August 8, 2024 / Monogram Technologies Inc. (NASDAQ:MGRM) ("Monogram" or the "Company"), an AI-driven robotics company focused on improving human health with an initial focus on orthopedic surgery, today announced that it has submitted a 510(k) premarket filing to the U.S. Food and Drug Administration (FDA) for the Company's mBôs TKA System. The application was submitted on July 19, 2024, and passed the FDA Administrative Review. An FDA decision is expected within 90 days of the initial submission; however, the process may be paused if additional information is requested.
Posted In: MGRM
