| Device Type ID | 3716 |
| Device Name | Fastener, Plate, Cranioplasty |
| Regulation Description | Cranioplasty Plate Fastener. |
| 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 | 882.5360 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | HBW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3716 |
| Device | Fastener, Plate, Cranioplasty |
| Product Code | HBW |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Cranioplasty Plate Fastener. |
| CFR Regulation Number | 882.5360 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
DEPUY SYNTHES COMPANIES OF JOHNSON & JOHNSON | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STRYKER | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
STRYKER CORP. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 15 |
Fracture | 6 |
Detachment Of Device Or Device Component | 5 |
Break | 2 |
Difficult To Insert | 2 |
Fitting Problem | 1 |
Device Operates Differently Than Expected | 1 |
Use Of Device Problem | 1 |
Deformation Due To Compressive Stress | 1 |
| Total Device Problems | 34 |