BEUDAMED
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    Conformis iTotal CR-Cruciate Retaining Knee Replacement System Model Numbers: M57250600010 iTotal CR, Left Knee M57250600020 iTotal CR, Right Knee Product Usage : Usage: The iTotal CR Knee Replacement System (KRS) is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patello-femoral or bi-compartmental prosthesis.

    FDA Enforcement
    Class II ·Terminated·Conformis Inc·August 29, 2012

    Screw Tulip , 6.25mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Recall
    Terminated ·NuVasive Inc·Product code NKB·January 5, 2009

    Screw Tulip , 5.5mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Recall
    Terminated ·NuVasive Inc·Product code NKB·January 5, 2009

    7.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Recall
    Terminated ·NuVasive Inc·Product code NKB·January 5, 2009

    7.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Recall
    Terminated ·NuVasive Inc·Product code NKB·January 5, 2009

    6.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Recall
    Terminated ·NuVasive Inc·Product code NKB·January 5, 2009

    6.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Recall
    Terminated ·NuVasive Inc·Product code NKB·January 5, 2009

    4.5mm x 35mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Recall
    Terminated ·NuVasive Inc·Product code NKB·January 5, 2009

    5.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Recall
    Terminated ·NuVasive Inc·Product code NKB·January 5, 2009

    7.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Recall
    Terminated ·NuVasive Inc·Product code NKB·January 5, 2009

    5.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Recall
    Terminated ·NuVasive Inc·Product code NKB·January 5, 2009

    5.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Recall
    Terminated ·NuVasive Inc·Product code NKB·January 5, 2009

    7.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Recall
    Terminated ·NuVasive Inc·Product code NKB·January 5, 2009

    5.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Recall
    Terminated ·NuVasive Inc·Product code NKB·January 5, 2009

    5.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Recall
    Terminated ·NuVasive Inc·Product code NKB·January 5, 2009

    7.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Recall
    Terminated ·NuVasive Inc·Product code NKB·January 5, 2009

    6.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Recall
    Terminated ·NuVasive Inc·Product code NKB·January 5, 2009

    6.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Recall
    Terminated ·NuVasive Inc·Product code NKB·January 5, 2009

    5.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Recall
    Terminated ·NuVasive Inc·Product code NKB·January 5, 2009

    6.5mm x 55mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI

    FDA Recall
    Terminated ·NuVasive Inc·Product code NKB·January 5, 2009