Device Type ID | 4545 |
Device Name | Positioner, Socket |
Regulation Description | Orthopedic Manual Surgical Instrument. |
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 | 888.4540 [🔎] |
FDA Device Classification | Class 1 Medical Device |
Product Code | KIL |
GMP Exempt | No |
Summary MR | Eligible |
Implanted Device | No |
Life Support Device | No |
Third Party Review | Not Third Party Eligible |