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U.S. Department of Health and Human Services

Product Classification

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Device anchor, suture, bone fixation, metallic
Regulation Description Single/multiple component metallic bone fixation appliances and accessories.
Definition This device is indicated for attaching suture into bone for suspension of the nasal valve and for attaching suture into bone at the lower orbital rim.
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeNOV
Premarket Review Restorative, Repair and Trauma Devices (DHT6C)
Restorative, Repair and Trauma Devices (DHT6C)
Submission Type 510(k)
Regulation Number 888.3030
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