Prosthesis, Wrist, Semi-constrained

Device Code: 4571

Product Code(s): KWM

Device Classification Information

Device Type ID4571
Device NameProsthesis, Wrist, Semi-constrained
Regulation DescriptionWrist Joint Metal/polymer Semi-constrained Cemented Prosthesis.
Regulation Medical SpecialtyOrthopedic
Review PanelOrthopedic
Premarket Review Office Of Device Evaluation (ODE)
Division Of Orthopedic Devices (DOD)
Joint And Fixation Devices Branch Two ¿ Hips/Wrists/Fingers (JFDB2)
Submission Type510(k)
CFR Regulation Number888.3800 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeKWM
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4571
DeviceProsthesis, Wrist, Semi-constrained
Product CodeKWM
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionWrist Joint Metal/polymer Semi-constrained Cemented Prosthesis.
CFR Regulation Number888.3800 [🔎]
TPLC Last Update: 2019-04-02 20:51:57

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