| Device Type ID | 3646 |
| Device Name | Plate, Cranioplasty, Preformed, Alterable |
| 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 | GWO |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3646 |
| Device | Plate, Cranioplasty, Preformed, Alterable |
| Product Code | GWO |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Preformed Alterable Cranioplasty Plate. |
| CFR Regulation Number | 882.5320 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ALLIANCE PARTNERS, LLC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
FLEXTRONICS INTERNATIONAL USA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
INNOVASIS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
JEIL MEDICAL CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
OSTEONIC CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STRYKER | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
STRYKER CORP. | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 60 |
Break | 32 |
Material Fragmentation | 4 |
Peeled / Delaminated | 3 |
Device Slipped | 3 |
Insufficient Information | 3 |
Fracture | 3 |
Device Operates Differently Than Expected | 3 |
Screw | 2 |
Component Missing | 1 |
Bent | 1 |
Migration Or Expulsion Of Device | 1 |
Failure To Adhere Or Bond | 1 |
Detachment Of Device Or Device Component | 1 |
Knife | 1 |
Difficult To Insert | 1 |
Dull, Blunt | 1 |
Positioning Problem | 1 |
Inadequacy Of Device Shape And/or Size | 1 |
Device-Device Incompatibility | 1 |
Material Separation | 1 |
| Total Device Problems | 125 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Biomet Microfixation, LLC | II | Oct-20-2015 |
| 2 | Stryker Leibinger GmbH & Co. KG | II | Aug-29-2018 |