Prosthesis, Finger, Constrained, Metal, Cemented

Device Code: 4591

Product Code(s): LBC

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

Device Classification Information

Device Type ID4591
Device NameProsthesis, Finger, Constrained, Metal, Cemented
Regulation DescriptionFinger Joint Metal/metal 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 TypePMA
CFR Regulation Number888.3210 [🔎]
FDA Device ClassificationClass 3 Medical Device
Product CodeLBC
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4591
DeviceProsthesis, Finger, Constrained, Metal, Cemented
Product CodeLBC
FDA Device ClassificationClass 3 Medical Device
Regulation DescriptionFinger Joint Metal/metal Constrained Cemented Prosthesis.
CFR Regulation Number888.3210 [🔎]
TPLC Last Update: 2019-04-02 20:52:22

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.