ACE Medical Company Receives 510(k) Approval from the FDA


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“Receiving the 510(k) gives us the ability to directly market and sell these products for use in neurosurgery and the spine, representing the largest market share of users for these devices. Our FDA clearance will open up significant domestic and global sales opportunities.”

ACE Medical Co. has been granted 510(k) clearance from the FDA in order to sell and market their surgical equipment for the use in the spine.

According to the FDA, “a 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device.”

This clearance comes as encouraging news to ACE Medical as this means their tried-and-true medical equipment brands has been deemed safe and effective. As a supplier of Kerrison’s tools for removing bone anatomy, ACE Medical can continue to help doctors relieve their patient’s pain and numbness of discogenic origin.

Alex Ebner, President and Founder at ACE Medical Co. has an extensive background and demonstrated history of working in the medical device industry. Ebner is a strong business development professional skilled in the spine and disposables.

“Receiving the 510(k) gives us the ability to directly market and sell these products for use in neurosurgery and the spine, representing the largest market share of users for these devices,” said Ebner. “Our FDA clearance will open up significant domestic and global sales opportunities.”

ACE Medical Co’s dedicated sales and support teams are trained in the most advanced techniques and latest generations of equipment. Known for their trusted expertise, leadership and dedication to bringing the highest quality service and supplies to our surgeons. ACE Medical supplies to physicians that are leaders in their areas of medicine and work collaboratively with them to provide extraordinary care and improved outcomes for patients.

About ACE Medical Co.

ACE Medical Co. is a medical equipment supplier in Cincinnati, Ohio. Their solution-based systems are designed to improve surgical outcomes for both patients and providers. Known for their trusted expertise, leadership and dedication to bringing the highest quality service and supplies to surgeons; they represent premier manufacturers of surgical instrumentation and equipment, for use by Cardiac, ENT, Facial/Plastic, Neuro, Spine and Thoracic specialists. Find more information at: http://www.acemedicalco.com.

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