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U.S. Department of Health and Human Services

Product Classification

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Device cranial surgical planning and instrument guides
Regulation Description Powered simple cranial drills, burrs, trephines, and their accessories.
Definition Software and hardware for surgical planning to create patient-specific anatomical models, surgical templates, and guides for use in the marking or cutting of cranial bone for neurosurgical procedures.
Physical State Software and hardware
Technical Method Pre-surgical planning including transferring, visualizing, and editing medical data. Patient-specific templates/guides are based on a pre-operative plan and are designed to fit a specific patient. These templates/guides are used to assist a surgeon in guiding the marking of bone and/or guiding surgical instruments.
Target Area Cranial bone
Regulation Medical Specialty Neurology
Review Panel Neurology
Product CodePPT
Premarket Review Office of Device Evaluation (ODE)
Division of Neurological and Physical Medicine Devices (DNPMD)
Neurointerventional Devices Branch (NIDB)
Submission Type 510(k)
Regulation Number 882.4310
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible