3 results
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8ms
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Sources: EU EUDAMED, US FDA
Ottobock Modular Polycentric EBS Knee Joint 3R60, 3R60=ST, 3R60=KD, 3R60=HD. Used for the prosthetic fitting of amputations of the lower. limb.
FDA Enforcement
Class II
·Terminated·Otto Bock Healthcare GmbH·January 13, 2016
Ottobock Pheon 3R62 Knee Joint The 3R62 Pheon is a polycentric prosthetic knee joint intended to be used solely for lower limb prosthetic fittings. It is available in several versions to allow attachment to other components based on the patient need and physiology.
FDA Enforcement
Class II
·Terminated·Otto Bock Healthcare GmbH·August 5, 2015
iOS Galileo Application Version 1.1.1 or lower that programs the Triton Smart Ankle; 1C66 Triton Smart Ankle, an external prosthetic ankle/foot.
FDA Enforcement
Class II
·Terminated·Otto Bock Healthcare GmbH·November 11, 2015