Product Code: MPW FDA class 3

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

Unknown

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.

510(k)s
0
FEI Numbers
3
Registration Numbers
3
Unique Applicants
0
Years Active

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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

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

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.