Definition: For Measuring The Depth Of A Passageway In Bone Or Tissue, Prior To Insertion Of Screws Or Other Hardware. The Device Is An Electronic Depth Gauge For Various Medical Purposes Including, Measuring The Depth Of A Passageway In A Bone Or Other Tissue.
| Device Type ID | 4664 |
| Device Name | Electronic Depth Gauge |
| Physical State | May Have Components Of Metal And Plastic, And Includes A Battery Or Power Source, An LCD Or Other Display, And Software And/or Firmware |
| Technical Method | Uses A Mechanical Sliding Probe, In Conjunction With Hardware That Creates A Variable Voltage Input Based On Probe Position And Software, To Display Digitally A Measured Depth |
| Target Area | Bone Or Tissue Sites Where Tunnels Or Steps Exist, Or Drilling Or Cutting Has Occurred |
| Regulation Description | Single/multiple Component Metallic Bone Fixation Appliances And Accessories. |
| Regulation Medical Specialty | Orthopedic |
| 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) |
| CFR Regulation Number | 888.3030 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | OOL |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
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| Device Type ID | 4664 |
| Device | Electronic Depth Gauge |
| Product Code | OOL |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Single/multiple Component Metallic Bone Fixation Appliances And Accessories. |
| CFR Regulation Number | 888.3030 [🔎] |