OJZ

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

Product code

OJZ

Device name

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

Device class

Class F

Medical specialty

Unknown

Marketing pathway

HDE - Humanitarian Device Exemption

Flag

Implant

FDA classification definition

Device type: Filler, recombinant human bone morphogenetic protein, collagen scaffold, osteoinduction, revision spine surgery, autograft not available or feasible - replacement for autograft bone in patients where autograft is unavailable or not feasible to harvest. Not feasible to harvest is intended to means presence of a condition where normal bone metabolism would be expected to prevent healing, e.G., smokers and diabetics. Revision spine surgery to treat pseudarthrosis.

Definition text from the FDA device classification database (U.S. federal government work, public domain).