Definition: A Nonalterable Cranial Bone Void Filler Is A Device That Is Created From Patient-specific Computerized Tomography (CT) Imaging Data And Intended To Fill Bony Voids, Defects, And Contour Irregularities In Non-load Bearing Regions Of The Cranial Skelet
| Device Type ID | 3785 |
| Device Name | Filler, Bone Void, Non-alterable Compound For Cranioplasty |
| Physical State | Manufactured As Patient-Specific 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 Description | Preformed Nonalterable Cranioplasty Plate. |
| Regulation Medical Specialty | Neurology |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurodiagnostic And Neurosurgical Devices Branch (NDNB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 882.5330 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PJN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3785 |
| Device | Filler, Bone Void, Non-alterable Compound For Cranioplasty |
| Product Code | PJN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Preformed Nonalterable Cranioplasty Plate. |
| CFR Regulation Number | 882.5330 [🔎] |