| 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 Code | PPT |
|---|
| Premarket Review |
Office of Neurological and Physical Medicine Devices
(OHT5)
Neurosurgical, Neurointerventional and Neurodiagnostic Devices
(DHT5A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
882.4310
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
No
|
|---|
| Third Party Review |
Not Third Party Eligible |
|
|
