| Device Type ID | 3663 |
| Device Name | Plate, Cranioplasty, Preformed, Non-alterable |
| Regulation Description | Preformed Nonalterable 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 | 882.5330 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | GXN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3663 |
| Device | Plate, Cranioplasty, Preformed, Non-alterable |
| Product Code | GXN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Preformed Nonalterable Cranioplasty Plate. |
| CFR Regulation Number | 882.5330 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
FIN-CERAMICA FAENZA SPA | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
JEIL MEDICAL CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KLS MARTIN GMBH + CO. KG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KLS MARTIN GMBH And CO. KG | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OSSDSIGN AB | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OSTEOSYMBIONICS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OXFORD PERFORMANCE MATERIALS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 55 |
Inadequacy Of Device Shape And/or Size | 19 |
Unintended Movement | 17 |
Device Operates Differently Than Expected | 16 |
Fitting Problem | 11 |
Loose Or Intermittent Connection | 8 |
Break | 7 |
Failure To Adhere Or Bond | 6 |
Use Of Device Problem | 5 |
Disassembly | 4 |
Fracture | 4 |
Material Deformation | 4 |
Insufficient Information | 3 |
Patient-Device Incompatibility | 3 |
Device Inoperable | 3 |
Improper Or Incorrect Procedure Or Method | 3 |
Material Integrity Problem | 2 |
Appropriate Term/Code Not Available | 2 |
Defective Device | 2 |
Device Markings / Labelling Problem | 2 |
Material Distortion | 2 |
Patient Device Interaction Problem | 2 |
Plate | 1 |
Device Issue | 1 |
Human Factors Issue | 1 |
Device Handling Problem | 1 |
Detachment Of Device Component | 1 |
Incorrect Device Or Component Shipped | 1 |
Difficult To Insert | 1 |
Detachment Of Device Or Device Component | 1 |
Mechanical Problem | 1 |
Difficult To Position | 1 |
Shipping Damage Or Problem | 1 |
Device Operational Issue | 1 |
| Total Device Problems | 192 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Kelyniam Global, Inc. | II | May-14-2018 |
| 2 | Synthes (USA) Products LLC | II | Sep-23-2015 |
| 3 | Zimmer Biomet, Inc. | II | Nov-06-2018 |