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U.S. Department of Health and Human Services

Product Classification

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Device suture, recombinant technology
Definition Intended for use in soft tissue approximation. Indicated for use in general soft tissue approximation and/or ligation.
Physical State Polymer (solid)
Technical Method Produced through recombinant DNA technology
Target Area General soft tissues in the body.
Regulation Medical Specialty General & Plastic Surgery
Review Panel Orthopedic
Product CodeNWJ
Premarket Review Orthopedic Devices (OHT6)
Joint Arthroplasty Devices (DHT6A)
Submission Type 510(k)
Regulation Number 878.4494
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? Yes
Life-Sustain/Support Device? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible