| Device Type ID | 4535 |
| Device Name | Instrument, Surgical, Sonic And Accessory/attachment |
| Regulation Description | Sonic Surgical Instrument And Accessories/attachments. |
| 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 | 888.4580 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | JDX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
|
| Device Type ID | 4535 |
| Device | Instrument, Surgical, Sonic And Accessory/attachment |
| Product Code | JDX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Sonic Surgical Instrument And Accessories/attachments. |
| CFR Regulation Number | 888.4580 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
MECTRON SPA | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Electrical /Electronic Property Problem | 19 |
Device Inoperable | 12 |
Material Integrity Problem | 11 |
Fracture | 10 |
Mechanical Problem | 9 |
Break | 6 |
Device Operates Differently Than Expected | 2 |
Device Sensing Problem | 2 |
Device Displays Incorrect Message | 1 |
Intermittent Continuity | 1 |
Unintended Power Up | 1 |
Disassembly | 1 |
Insufficient Information | 1 |
Unintended Movement | 1 |
| Total Device Problems | 77 |