Ideal Implant Incorporated

CLOSEOUT LETTER Ideal Implant Incorporated MARCS-CMS 606103 — July 15, 2021 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Product: Medical Devices Recipient: Recipient Name Robert S. Hamas, MD Recipient Title CEO and President Ideal Implant Incorporated 14881 Quorum Drive Suite 925 Dallas , TX 75254 United States rhamas@idealimplant.com Issuing Office: Center for Devices and Radiological Health United States Dear Mr. Hamas: The Food and Drug Administration has completed an evaluation of your corrective actions in response to our Warning Letter dated May 14, 2020. Based on our evaluation, it appears that you have addressed the violation(s) contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections. This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. Sincerely, /S/ Jessica Mu, Director, Compliance Branch Office of Medical Devices and Radiological Health, Division III Content current as of: 07/21/2021 Regulated Product(s) Medical Devices