Product Code: OZJ FDA not classified

Inhibitor, Postoperative Fibrosis (Adhesion Barrier)

Unknown

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.

510(k)s
0
FEI Numbers
1
Registration Numbers
1
Unique Applicants
0
Years Active

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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

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

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.