FDA-Device2020-04-01Class II
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.
Intellijoint Surgical, Inc.
Hazard
During total knee arthroplasty (TKA), the software may incorrectly calculate femur resection depth.
Sold states
Worldwide distribution - US Nationwide distribution in the states of NY and CT. Country of Canada.
Affected count
N/A
Manufactured in
60 Bathurst Dr Unit 1, N/A, Waterloo, N/A, Canada
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1559-2020Don't want to check this manually?
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