FDA 510(k) Applications for Medical Device Product Code "NDF"
(Plate, Fixation, Bone, Non-Spinal, Metallic)

FDA 510(k) Number Applicant Device Name Decision Date
K010551 EBI, L.P. EBI DYNAFIX VS OSTEOTOMY SYSTEM 05/17/2001
K021749 EBI, L.P. EBI DYNAFIX VS OSTEOTOMY SYSTEM 08/12/2002
K051642 I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH FR.O.H. CALCANEUS REPAIR SYSTEM 08/22/2005


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