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U.S. Department of Health and Human Services

Product Classification

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Device filler, bone void, alterable compound for cranioplasty
Regulation Description Preformed alterable cranioplasty plate.
Definition An alterable cranial bone void filler is a device intended to be a bone substitute for the replacement of bony voids, defects, and contour irregularities in non-load bearing regions of the cranial skeleton, and are not intrinsic to the stability of the bony structure. The device is constructed from a material (e.g., calcium, polymer synthetic-based, etc.) that can be reshaped or altered at the time of surgery or after implantation without changing the chemical behavior of the material.
Physical State Preformed Implant
Technical Method The device is implanted in the bony void and may be secured using plates and screws to prevent the movement of the cranial bone void filler.
Target Area Cranium, Skull
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodePJM
Premarket Review Office of 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
Implanted Device? Yes
Life-Sustain/Support Device? No
Recognized Consensus Standard
Third Party Review Not Third Party Eligible