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U.S. Department of Health and Human Services

Product Classification
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Device system, facet screw spinal device
Review Panel Orthopedic
Product CodeMRW
Premarket Review Office of Orthopedic Devices (OHT6)
Spinal Devices (DHT6B)
Unclassified Reason Pre-Amendment
Submission Type 510(k)
Device Class Unclassified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Guidance Document
Third Party Review Not Third Party Eligible
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