Inhibitor, Postoperative Fibrosis (Adhesion Barrier)
The Inhibitor, Postoperative Fibrosis (Adhesion Barrier) is a neurology-related device designed to coat surfaces exposed during tendon and peripheral nerve surgery, forming a temporary mechanical barrier that separates tissues to reduce fibrosis and adhesion formation postoperatively. It is FDA not classified, with product code OZJ reviewed under the neurology panel. The device is pending classification, no regulation number has been assigned, and it does not carry implant or life-sustaining flags.
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Basic Information
- Product Code
- OZJ
- Device Class
- FDA not classified
- Medical Specialty
- Unknown
- Review Panel
- NE
- Submission Type
- 3
Device Characteristics
Definition
The device is designed to coat surfaces exposed in tendon and peripheral nerve surgery, in order to form a temporary mechanical barrier that separates tissues for the purpose of reducing fibrosis and reducing the formation of adhesions.
Unclassified Reason
3
FEI Numbers
This FDA classification entry is associated with 1 FEI number. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 1 registration number. Click on an entry to view related FDA registrations.