Ligaments And Tendons, Synthetic

Device Code: 4707

Product Code(s): LML

Device Classification Information

Device Type ID4707
Device NameLigaments And Tendons, Synthetic
Review PanelOrthopedic
Premarket Review Office Of Device Evaluation (ODE)
Division Of Orthopedic Devices (DOD)
Restorative And Repair Devices Branch (RRDB)
Submission TypePMA
FDA Device ClassificationClass 3 Medical Device
Product CodeLML
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4707
DeviceLigaments And Tendons, Synthetic
Product CodeLML
FDA Device ClassificationClass 3 Medical Device
TPLC Last Update: 2019-04-02 20:54:14

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