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 |