| Device Type ID | 5176 |
| Device Name | Pylon, Post Surgical |
| Regulation Description | Prosthetic And Orthotic Accessory. |
| Regulation Medical Specialty | Physical Medicine |
| Review Panel | Physical Medicine |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Physical Medicine And Rehabilitation Devices Branch (PMDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 890.3025 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | ISM |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5176 |
| Device | Pylon, Post Surgical |
| Product Code | ISM |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Prosthetic And Orthotic Accessory. |
| CFR Regulation Number | 890.3025 [🔎] |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | MED-EL Elektromedizinische Gereate, Gmbh | II | Mar-02-2017 |