Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction - Hde, Long Bone Nonunion
OKD · f · Unknown
Classification
FDA Product Code
OKD
Device class
f
Regulation
—
Review panel
OR
Medical specialty
Unknown
Submission type
6
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N
Definition
Bone graft substitute when autograft is unavailable or unfeasible to harvest for treatment of recalcitrant long bone non-unions where normal bone metabolism and healing is not present, e.g., smokers and diabetics.