Inhibitor, Postoperative Fibrosis (Adhesion Barrier)

OZJ · Not classified · Unknown

Classification

FDA Product Code: OZJ
Device class: Not classified
Regulation: —
Review panel: NE
Medical specialty: Unknown
Submission type: 3
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 1

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown