Prosthesis, Finger, Polymer

Device Code: 4564

Product Code(s): KWF

Device Classification Information

Device Type ID4564
Device NameProsthesis, Finger, Polymer
Regulation DescriptionFinger Joint Polymer Constrained 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 Number888.3230 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeKWF
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4564
DeviceProsthesis, Finger, Polymer
Product CodeKWF
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionFinger Joint Polymer Constrained Prosthesis.
CFR Regulation Number888.3230 [🔎]
Device Problems
Fracture
17
Adverse Event Without Identified Device Or Use Problem
6
Break
4
Migration
2
Total Device Problems 29
TPLC Last Update: 2019-04-02 20:51:51

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