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 T
| Device Type ID | 3784 |
| Device Name | Filler, Bone Void, Alterable Compound For Cranioplasty |
| 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 Description | Preformed Alterable 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 | 882.5320 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PJM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
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| Device Type ID | 3784 |
| Device | Filler, Bone Void, Alterable Compound For Cranioplasty |
| Product Code | PJM |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Preformed Alterable Cranioplasty Plate. |
| CFR Regulation Number | 882.5320 [🔎] |