35 results
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14ms
·
Sources: EU EUDAMED, US FDA
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 , 5.5mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
Screw Tulip , 6.25mm Rod Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
6.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
6.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
6.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
5.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
6.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
7.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
4.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
7.5mm x 45mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
6.5mm x 35mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
5.5mm x 30mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
7.5mm x 40mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
5.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
6.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
5.5mm x 50mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
7.5mm x 40mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
7.5mm x 45mm Noncannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012
7.5mm x 50mm Cannulated Screw Shank Subsequent Codes: KWP, KWQ, MNH, MNI
FDA Enforcement
Class II
·Terminated·NuVasive Inc·November 28, 2012