| Device Type ID | 3665 |
| Device Name | Methyl Methacrylate For Cranioplasty |
| Regulation Description | Methyl Methacrylate For Cranioplasty. |
| 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 | 882.5300 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | GXP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3665 |
| Device | Methyl Methacrylate For Cranioplasty |
| Product Code | GXP |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Methyl Methacrylate For Cranioplasty. |
| CFR Regulation Number | 882.5300 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
STRYKER | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STRYKER CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 5 |
Device Operational Issue | 3 |
Migration Or Expulsion Of Device | 2 |
Device Operates Differently Than Expected | 2 |
Failure To Adhere Or Bond | 2 |
Improper Or Incorrect Procedure Or Method | 1 |
Coagulation In Device Or Device Ingredient | 1 |
Loss Of Or Failure To Bond | 1 |
Use Of Device Problem | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Device Expiration Issue | 1 |
Defective Device | 1 |
| Total Device Problems | 21 |