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U.S. Department of Health and Human Services

Product Classification
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Device mesh, surgical, collagen, orthopaedics, reinforcement of tendon
Regulation Description Surgical mesh.
Definition For reinforcement of soft tissue where weakness exists in tendon repair.
Physical State A collagen mesh; either square, rectangular, round or of various other shapes.
Technical Method A collagen mesh that reinforces soft tissue.
Target Area Tendon
Regulation Medical Specialty General & Plastic Surgery
Review Panel Orthopedic
Product CodeOWY
Premarket Review Office of Orthopedic Devices (OHT6)
Restorative, Repair and Trauma Devices (DHT6C)
Submission Type 510(k)
Regulation Number 878.3300
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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