Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction

Device Code: 4727

Product Code(s): MPW

Definition: Pma Approved: P000054

Device Classification Information

Device Type ID4727
Device NameFiller, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction
Review PanelOrthopedic
Premarket Review Office Of Device Evaluation (ODE)
Division Of Neurological And Physical Medicine Devices (DNPMD)
Physical Medicine And Rehabilitation Devices Branch (PMDB)
Submission TypePMA
FDA Device ClassificationClass 3 Medical Device
Product CodeMPW
GMP ExemptNo
Summary MREligible
Implanted DeviceYes
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID4727
DeviceFiller, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction
Product CodeMPW
FDA Device ClassificationClass 3 Medical Device
TPLC Last Update: 2019-04-02 20:54:32

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