Device Type ID | 4603 |
Device Name | Accessories, Fixation, Spinal Interlaminal |
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 | LYP |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | Yes |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |