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U.S. Department of Health and Human Services

Product Classification

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Device plate, cranioplasty, preformed, alterable
Regulation Description Preformed alterable cranioplasty plate.
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodeGWO
Premarket Review Neurological and Physical Medicine Devices (OHT5)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Submission Type 510(k)
Regulation Number 882.5320
Device Class 2
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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