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U.S. Department of Health and Human Services

Product Classification
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Device mesh, surgical, non-resorbable, orthopedics, reinforcement of ligament
Regulation Description Surgical mesh.
Definition a non-resorbable orthopedic mesh used for reinforcement of soft tissue where weakness exists in ligament repair.
Physical State A non-resorbable mesh, either square, rectangular, tape-like, or various other shapes
Technical Method A mesh that reinforces soft tissue to support the primary repair
Target Area Ligament
Regulation Medical Specialty General & Plastic Surgery
Review Panel Orthopedic
Product CodeQUW
Premarket Review Restorative, Repair and Trauma Devices (DHT6C)
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		 Ineligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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