QUW

4 FDA 510(k) clearances · Product code

FDA profile

Official device name

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

Device class

Class II (moderate risk)

Regulation

21 CFR 878.3300

Medical specialty

General, Plastic Surgery

Flags

Implant

FDA definition

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

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