Product code QUW

Device name

Mesh, Surgical, Non-Resorbable, Orthopedics, Reinforcement Of Ligament

Medical specialty

General, Plastic Surgery

Device class

2

Regulation number

878.3300

Review panel

OR

Implant

Y

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

a non-resorbable orthopedic mesh used for reinforcement of soft tissue where weakness exists in ligament repair.

Source

FDA openFDA device classification dataset