| Device Type ID | 4477 |
| Device Name | Gauge, Depth |
| Regulation Description | Depth Gauge For Clinical Use. |
| 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) Exempt |
| CFR Regulation Number | 888.4300 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | HTJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4477 |
| Device | Gauge, Depth |
| Product Code | HTJ |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Depth Gauge For Clinical Use. |
| CFR Regulation Number | 888.4300 [🔎] |
| Device Problems | |
|---|---|
Break | 284 |
Material Fragmentation | 45 |
Component Missing | 35 |
Device Operates Differently Than Expected | 27 |
Incorrect Measurement | 24 |
Mechanical Jam | 21 |
Bent | 19 |
Sticking | 15 |
Fracture | 12 |
Fitting Problem | 7 |
Detachment Of Device Or Device Component | 6 |
Naturally Worn | 4 |
Device Reprocessing Problem | 4 |
Difficult To Remove | 3 |
Particulates | 3 |
Appropriate Term/Code Not Available | 3 |
Misassembled | 3 |
Failure To Align | 3 |
Device Markings / Labelling Problem | 3 |
Calibration Problem | 2 |
Output Problem | 2 |
Difficult To Position | 2 |
Material Separation | 2 |
Material Twisted / Bent | 2 |
Display Difficult To Read | 2 |
Device Contamination With Body Fluid | 1 |
Material Discolored | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Gauges/Meters | 1 |
Metal Shedding Debris | 1 |
Disassembly | 1 |
Material Too Rigid Or Stiff | 1 |
Device-Device Incompatibility | 1 |
Detachment Of Device Component | 1 |
Packaging Problem | 1 |
Insufficient Information | 1 |
Mechanical Problem | 1 |
Positioning Problem | 1 |
Component Falling | 1 |
Dull, Blunt | 1 |
| Total Device Problems | 548 |