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U.S. Department of Health and Human Services

Product Classification

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Device prosthestic disc nucleus device
Definition Export only.
Physical State Export Only
Technical Method Export Only
Target Area Export Only
Review Panel Orthopedic
Product CodeMQO
Premarket Review Office of Device Evaluation (ODE)
Division of Orthopedic Devices (DOD)
Joint and Fixation Devices Branch Two ¿ Hips/Wrists/Fingers (JFDB2)
Not Classified Reason For Export Only
Submission Type Contact ODE
Device Class Not Classified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Third Party Review Not Third Party Eligible
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