| Device Type ID | 4538 |
| Device Name | Component, Traction, Invasive |
| Regulation Description | Smooth Or Threaded Metallic Bone Fixation Fastener. |
| 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) |
| CFR Regulation Number | 888.3040 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | JEC |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4538 |
| Device | Component, Traction, Invasive |
| Product Code | JEC |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Smooth Or Threaded Metallic Bone Fixation Fastener. |
| CFR Regulation Number | 888.3040 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
HAND BIOMECHANICS LAB, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VIRAK ORTHOPEDIC RESEARCH, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Break | 6 |
Unintended Movement | 4 |
Adverse Event Without Identified Device Or Use Problem | 3 |
Patient Device Interaction Problem | 2 |
Difficult To Advance | 2 |
Malposition Of Device | 1 |
Mechanical Problem | 1 |
Detachment Of Device Or Device Component | 1 |
Material Fragmentation | 1 |
Mechanical Jam | 1 |
Device Maintenance Issue | 1 |
Component Missing | 1 |
No Apparent Adverse Event | 1 |
Difficult To Remove | 1 |
| Total Device Problems | 26 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Hand Biomechanics Lab Inc | II | Oct-18-2016 |
| 2 | Ossur Americas | II | Mar-11-2019 |