Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction
The Recombinant Human Bone Morphogenetic Protein / Collagen Scaffold Osteoinductive Filler is an orthopedic implant combining a recombinant human bone morphogenetic protein with a collagen carrier to stimulate bone formation and fill bone defects. Classified as FDA Class 3 under PMA approval P000054, it requires Premarket Approval due to the novel biological activity of the bone morphogenetic protein component. The product code is MPW, and it carries an implant flag.
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Basic Information
- Product Code
- MPW
- Device Class
- FDA class 3
- Medical Specialty
- Unknown
- Review Panel
- OR
- Submission Type
- 2
Device Characteristics
Definition
Pma approved: P000054
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.