| Device Type ID | 4495 |
| Device Name | Instrument, Compression |
| 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 Two ¿ Hips/Wrists/Fingers (JFDB2) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 888.4540 [🔎] |
| FDA Device Classification | Class 1 Medical Device |
| Product Code | HWN |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 4495 |
| Device | Instrument, Compression |
| Product Code | HWN |
| FDA Device Classification | Class 1 Medical Device |
| Regulation Description | Orthopedic Manual Surgical Instrument. |
| CFR Regulation Number | 888.4540 [🔎] |
| Device Problems | |
|---|---|
Break | 43 |
Appropriate Term/Code Not Available | 8 |
Crack | 7 |
Component Missing | 6 |
Material Fragmentation | 5 |
Fracture | 3 |
Adverse Event Without Identified Device Or Use Problem | 2 |
Device-Device Incompatibility | 2 |
Material Deformation | 1 |
Inadequacy Of Device Shape And/or Size | 1 |
Fitting Problem | 1 |
Mechanical Jam | 1 |
Torn Material | 1 |
Insufficient Information | 1 |
Loose Or Intermittent Connection | 1 |
Scratched Material | 1 |
Connection Problem | 1 |
Material Split, Cut Or Torn | 1 |
Sparking | 1 |
Device Operates Differently Than Expected | 1 |
Material Twisted / Bent | 1 |
Failure To Adhere Or Bond | 1 |
Flare Or Flash | 1 |
| Total Device Problems | 91 |