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U.S. Department of Health and Human Services

Product Classification
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Device prosthetic 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 Orthopedic Devices (OHT6)
Spinal Devices (DHT6B)
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
Summary Malfunction
Reporting		 Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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