| Device Type ID | 5153 |
| Device Name | Orthosis, Cervical |
| Regulation Description | Truncal Orthosis. |
| 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 | 890.3490 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | IQK |
| GMP Exempt | Yes |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 5153 |
| Device | Orthosis, Cervical |
| Product Code | IQK |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Truncal Orthosis. |
| CFR Regulation Number | 890.3490 [🔎] |
| Device Problems | |
|---|---|
Fracture | 32 |
Adverse Event Without Identified Device Or Use Problem | 3 |
Break | 3 |
Device Operates Differently Than Expected | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
| Total Device Problems | 40 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Ossur H / F | II | Mar-31-2016 |