| Device Type ID | 4699 |
| Device Name | Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment |
| Regulation Description | Surgical Instrument Motors And Accessories/attachments. |
| Regulation Medical Specialty | General & Plastic Surgery |
| Review Panel | Orthopedic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Orthopedic Devices (DOD) Joint And Fixation Devices Branch Two ¿ Hips/Wrists/Fingers (JFDB2) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 878.4820 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | KIJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4699 |
| Device | Instrument, Surgical, Orthopedic, Dc-powered Motor And Accessory/attachment |
| Product Code | KIJ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Surgical Instrument Motors And Accessories/attachments. |
| CFR Regulation Number | 878.4820 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
JEIL MEDICAL CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Unintended Power Up | 5 |
Disassembly | 5 |
Smoking | 4 |
Fluid Leak | 4 |
Overheating Of Device | 3 |
Battery Problem | 3 |
Metal Shedding Debris | 2 |
Device Inoperable | 1 |
Failure To Shut Off | 1 |
Leak / Splash | 1 |
| Total Device Problems | 29 |