ConforMIS, Inc. (NASDAQ:CFMS) Files An 8-K Other Events
Item 8.01
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Other Events.
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clearance from the U.S. Food and Drug Administration to market
the iTotal Hip, the Companys primary total hip replacement
implant system. On June 20, 2017, the Company issued a press
release announcing the 510(k) clearance. A copy of the press
release is furnished herewith as Exhibit 99.1 and is incorporated
into this Item 8.01 by reference.
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Item 9.01
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Financial Statements and Exhibits.
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(d)
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Exhibits.
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Exhibit No.
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Description
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99.1*
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Press Release of ConforMIS, Inc., dated June 20, 2017
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ConforMIS Inc ExhibitEX-99.1 2 ex991.htm EXHIBIT 99.1 Exhibit ConforMIS Announces FDA 510(k) Clearance for iTotal Hip SystemNew hip replacement implant system builds on ConforMIS’s customized knee replacement technology and positions Company to expand in global orthopedics marketBILLERICA,…To view the full exhibit click here About ConforMIS, Inc. (NASDAQ:CFMS)
ConforMIS, Inc. is a medical technology company that uses its iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants. The Company’s products include iTotal CR, which is the cruciate-retaining, customized total knee replacement system to restore the natural shape of a patient’s knee; iTotal PS, which is the posterior cruciate ligament substituting, or posterior-stabilized, customized total knee replacement product to restore the natural shape of a patient’s knee; iDuo, which is the customized bicompartmental knee replacement system, and iUni, which is the customized unicompartmental knee replacement product for treatment of the medial or lateral compartment of the knee. Its iFit technology platform comprises three elements: iFit Design, iFit Printing and iFit Just-in-Time Delivery. The Company markets and sells its products in the United States, Germany, the United Kingdom, Austria, Ireland, Switzerland, Singapore and Hong Kong.
