Product code OWW

Device name

Mesh, Surgical, Absorbable, Orthopaedics, Reinforcement Of Tendon

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

Eligible

Definition

For reinforcement of soft tissue where weakness exists during tendon repair procedures.

Source

FDA openFDA device classification dataset