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U.S. Department of Health and Human Services

Product Classification

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Device fixation accessory
Regulation Description Single/multiple component metallic bone fixation appliances and accessories.
Regulation Medical Specialty Orthopedic
Review Panel Orthopedic
Product CodeLYT
Premarket Review Office of Device Evaluation (ODE)
Division of Orthopedic Devices (DOD)
Joint and Fixation Devices Branch Two ¿ Hips/Wrists/Fingers (JFDB2)
Submission Type 510(k)
Regulation Number 888.3030
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Third Party Review Not Third Party Eligible
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