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U.S. Department of Health and Human Services

Product Classification
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Device cranial distraction system
Regulation Description Preformed nonalterable cranioplasty plate.
Definition A cranial distraction system is a metal device intended to establish osteodistraction and bone growth in the skull. The bone segments are attached to the plate with screws to prevent movement of the segments.
Physical State May include: distractors, distraction plates, spacers, screws and instrumentation
Technical Method Bone segments are attached to the plate with screws to prevent movement of the segments.
Target Area Cranium, skull
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodePBJ
Premarket Review Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices (DHT5A)
Submission Type 510(k)
Regulation Number 882.5330
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? Yes
Third Party Review Not Third Party Eligible
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