FDA 510(k) Applications for Medical Device Product Code "NJD"
(Prosthesis, Knee, Femorotibial, Semi-Constrained, Unicompartmental/Unicondylar, Uncemented, Porous-Coated, Metal/Polymer)

FDA 510(k) Number Applicant Device Name Decision Date
K190439 Engage UNI, LLC EngageÖ Partial Knee System 11/21/2019
K133811 MAKO SURGICAL CORP. RESTORIS POROUS PARTIAL KNEE SYSTEM 07/08/2014
K222653 Smith+Nephew, Inc JOURNEY II UKÖ and ENGAGEÖ Cementless Partial Knee System 10/28/2022


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