510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OJZHumanitarian device exemption

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

Unknown
FDA source (opens on fda.gov)

OJZ is the FDA product code for Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction - Hde. FDA's definition for this code reads: "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...". As of , FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code
OJZ
Device name
Filler, Recombinant Human Bone Morphogenetic Protein, Collagen Scaffold, Osteoinduction - Hde
FDA 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.
Device class
Humanitarian device exemption
Review panel
Unknown
Submission type
FDA code 6
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code OJZ.