Prosthesis, Finger, Constrained, Metal, Uncemented

Device Code: 4563

Product Code(s): KWE

Definition: Call For Pmas To Be Filed By 12/26/96 Per 61 FR 50709 On 9/27/96

Device Classification Information

Device Type ID4563
Device NameProsthesis, Finger, Constrained, Metal, Uncemented
Regulation DescriptionFinger Joint Metal/metal Constrained Uncemented 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 TypePMA
CFR Regulation Number888.3200 [🔎]
FDA Device ClassificationClass 3 Medical Device
Product CodeKWE
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4563
DeviceProsthesis, Finger, Constrained, Metal, Uncemented
Product CodeKWE
FDA Device ClassificationClass 3 Medical Device
Regulation DescriptionFinger Joint Metal/metal Constrained Uncemented Prosthesis.
CFR Regulation Number888.3200 [🔎]
TPLC Last Update: 2019-04-02 20:51:50

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