| Device Type ID | 4536 |
| Device Name | Evacuator, Vapor, Cement Monomer |
| Regulation Description | Cement Monomer Vapor Evacuator. |
| Regulation Medical Specialty | Orthopedic |
| 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) Exempt |
| CFR Regulation Number | 888.4220 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | JDY |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4536 |
| Device | Evacuator, Vapor, Cement Monomer |
| Product Code | JDY |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Cement Monomer Vapor Evacuator. |
| CFR Regulation Number | 888.4220 [🔎] |
| Device Problems | |
|---|---|
Device Contaminated During Manufacture Or Shipping | 2 |
Device Contamination With Chemical Or Other Material | 1 |
Break | 1 |
Infusion Or Flow Problem | 1 |
Loss Of Or Failure To Bond | 1 |
| Total Device Problems | 6 |