| Device Type ID | 4701 |
| Device Name | Cement Obturator |
| Regulation Description | Surgical Mesh. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Joint And Fixation Devices Branch One ¿ Knees/Shoulders/Elbows/Ankles/Toes (JFDB1) |
| Submission Type | 510(k) |
| CFR Regulation Number | 878.3300 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LZN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4701 |
| Device | Cement Obturator |
| Product Code | LZN |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Surgical Mesh. |
| CFR Regulation Number | 878.3300 [🔎] |
| Device Problems | |
|---|---|
Patient-Device Incompatibility | 48 |
Insufficient Information | 3 |
Packaging Problem | 2 |
Failure To Osseointegrate | 2 |
Fracture | 1 |
Tear, Rip Or Hole In Device Packaging | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Loss Of Or Failure To Bond | 1 |
Difficult To Position | 1 |
| Total Device Problems | 60 |