4 results
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37ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Intellijoint Navigation System, Software Application, IJK1 (P/N 000-0547) - Product Usage: The Intellijoint Navigation System is a computer-controlled, optical localizer intended to provide intra-operative measurements to a surgeon to aid in selection and positioning of orthopedic implant system components, where a reference to a rigid anatomical structure can be identified.
FDA Recall
Terminated
·Intellijoint Surgical, Inc.·Product code OLO·February 11, 2020
Workstation, G2, Configured (P/N 000-0241)
FDA Recall
Terminated
·Intellijoint Surgical, Inc.·Product code OLO·June 28, 2019
Workstation, G2, Configured (P/N 000-0241)
FDA Enforcement
Class II
·Terminated·Intellijoint Surgical, Inc.·August 14, 2019
Intellijoint Navigation System, Software Application, IJK1 (P/N 000-0547) - Product Usage: The Intellijoint Navigation System is a computer-controlled, optical localizer intended to provide intra-operative measurements to a surgeon to aid in selection and positioning of orthopedic implant system components, where a reference to a rigid anatomical structure can be identified.
FDA Enforcement
Class II
·Terminated·Intellijoint Surgical, Inc.·April 1, 2020