Prosthesis, Knee, Patello/femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/metal/polymer

Device Code: 4717

Product Code(s): MBD

Device Classification Information

Device Type ID4717
Device NameProsthesis, Knee, Patello/femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Review PanelOrthopedic
Premarket Review Office Of Device Evaluation (ODE)
Division Of Orthopedic Devices (DOD)
Joint And Fixation Devices Branch One ¿ Knees/Shoulders/Elbows/Ankles/Toes (JFDB1)
Submission TypePMA
FDA Device ClassificationClass 3 Medical Device
Product CodeMBD
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4717
DeviceProsthesis, Knee, Patello/femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Product CodeMBD
FDA Device ClassificationClass 3 Medical Device
Device Problems
Insufficient Information
1
Fracture
1
Total Device Problems 2
TPLC Last Update: 2019-04-02 20:54:22

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