| Device Type ID | 4714 |
| Device Name | Monitor, Pressure, Intracompartmental |
| 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) |
| FDA Device Classification | Class Unclassified Medical Device |
| Product Code | LXC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4714 |
| Device | Monitor, Pressure, Intracompartmental |
| Product Code | LXC |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
TWIN STAR MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Device Operates Differently Than Expected | 2 |
Device Displays Incorrect Message | 1 |
Unable To Obtain Readings | 1 |
Probe | 1 |
| Total Device Problems | 5 |