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1 FDA 510(k) clearances · Product code

FDA profile

Official device name

Mesh, Surgical, Polymeric, 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

For reinforcement of soft tissue where weakness exists in ligament repair

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