Device Type ID | 4473 |
Device Name | Unit, Traction, Hip, Non-powered, Non-penetrating |
Regulation Description | Noninvasive Traction Component. |
Regulation Medical Specialty | Orthopedic |
Review Panel | Orthopedic |
Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Restorative And Repair Devices Branch (RRDB) |
Submission Type | 510(K) Exempt |
CFR Regulation Number | 888.5890 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | HSR |
GMP Exempt | Yes |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |
Device Type ID | 4473 |
Device | Unit, Traction, Hip, Non-powered, Non-penetrating |
Product Code | HSR |
FDA Device Classification | Class 1 Medical Device |
Regulation Description | Noninvasive Traction Component. |
CFR Regulation Number | 888.5890 [🔎] |