| Device Type ID | 4549 |
| Device Name | Component, Traction, Non-invasive |
| Regulation Description | Noninvasive Traction Component. |
| 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 | 888.5890 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | KQZ |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4549 |
| Device | Component, Traction, Non-invasive |
| Product Code | KQZ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Noninvasive Traction Component. |
| CFR Regulation Number | 888.5890 [🔎] |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Ossur Americas | II | Mar-11-2019 |
| 2 | Ossur H / F | II | Apr-19-2016 |