Glenoid Fossa Prosthesis

Device Code: 1323

Product Code(s): MPI

Device Classification Information

Device Type ID1323
Device NameGlenoid Fossa Prosthesis
Regulation DescriptionGlenoid Fossa Prosthesis.
Regulation Medical SpecialtyDental
Review PanelDental
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
Dental Devices Branch (DEDB)
Submission TypePMA
CFR Regulation Number872.3950 [🔎]
FDA Device ClassificationClass 3 Medical Device
Product CodeMPI
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1323
DeviceGlenoid Fossa Prosthesis
Product CodeMPI
FDA Device ClassificationClass 3 Medical Device
Regulation DescriptionGlenoid Fossa Prosthesis.
CFR Regulation Number872.3950 [🔎]
Device Problems
Adverse Event Without Identified Device Or Use Problem
1
Component Missing
1
Total Device Problems 2
TPLC Last Update: 2019-04-02 19:52:01

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