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Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon

FDA product code OWY · 13 cleared devices

Class 2 General, Plastic Surgery
Regulation
21 CFR 878.3300
Review panel
OR
Implant
Yes
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2012-11-08 – 2025-09-30

For reinforcement of soft tissue where weakness exists in tendon repair.

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