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.
| Device Type ID | 3794 |
| Device Name | Cranial Surgical Planning And Instrument Guides |
| 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 I |
| Target Area | Cranial Bone |
| Regulation Description | Powered Simple Cranial Drills, Burrs, Trephines, And Their Accessories. |
| Regulation Medical Specialty | Neurology |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurointerventional Devices Branch (NIDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 882.4310 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PPT |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3794 |
| Device | Cranial Surgical Planning And Instrument Guides |
| Product Code | PPT |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Powered Simple Cranial Drills, Burrs, Trephines, And Their Accessories. |
| CFR Regulation Number | 882.4310 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
VIDAR SYSTEMS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |