FDA 510(k) Applications for Medical Device Product Code "NEI"
(Prosthesis, Condyle, Mandibular, Temporary)

FDA 510(k) Number Applicant Device Name Decision Date
K990667 KLS-MARTIN L.P. KLS-MARTIN TEMPORARY CONDYLAR IMPLANT 07/27/2001
K031701 OSTEOMED L.P. OSTEOMED TEMPORARY CONDYLAR ATTACHMENT SYSTEM 07/08/2004
K133285 Stryker STRYKER TEMPORARY CONDYLAR PROSTHESIS 04/09/2014
K081747 SYNTHES (USA) MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM 09/05/2008
K063181 SYNTHES (USA) SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM 01/05/2007
K990637 SYNTHES (USA) SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEAD 10/22/1999
K002790 WALTER LORENZ SURGICAL, INC. ADD-ON CONDYLE 08/06/2001


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