Definition: This Device Is A Plate That Is Attached To The Lamina After A Laminoplasty Or Laminectomy Procedure.
| Device Type ID | 4648 |
| Device Name | Orthosis, Spine, Plate, Laminoplasty, Metal |
| Regulation Description | Spinal Interlaminal Fixation Orthosis. |
| Regulation Medical Specialty | Orthopedic |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Posterior Spine Devices Branch (PSDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 888.3050 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NQW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4648 |
| Device | Orthosis, Spine, Plate, Laminoplasty, Metal |
| Product Code | NQW |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Spinal Interlaminal Fixation Orthosis. |
| CFR Regulation Number | 888.3050 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CHOICE SPINE, LP | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GLOBUS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LIFE SPINE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SEASPINE ORTHOPEDICS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
X-SPINE SYSTEMS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
X-SPINE SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Device Markings / Labelling Problem | 12 |
Adverse Event Without Identified Device Or Use Problem | 7 |
Migration Or Expulsion Of Device | 6 |
Break | 3 |
Device Dislodged Or Dislocated | 2 |
Disassembly | 1 |
Fracture | 1 |
| Total Device Problems | 32 |