Prosthesis, Wrist, Carpal Scaphoid

Device Code: 4573

Product Code(s): KWO

Device Classification Information

Device Type ID4573
Device NameProsthesis, Wrist, Carpal Scaphoid
Regulation DescriptionWrist Joint Carpal Scaphoid Polymer 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 Number888.3760 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeKWO
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4573
DeviceProsthesis, Wrist, Carpal Scaphoid
Product CodeKWO
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionWrist Joint Carpal Scaphoid Polymer Prosthesis.
CFR Regulation Number888.3760 [🔎]
Device Problems
Unintended Movement
1
Migration Or Expulsion Of Device
1
Total Device Problems 2
TPLC Last Update: 2019-04-02 20:51:59

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