Panels › Orthopedic › Product code LOF · Class 2
Stimulator, Bone Growth, Non-Invasive
Regulation 890.5870
1510(k)s in 12 months (1 all time)
0recalls in 12 months (5 all time)
0recalls that name a 510(k)
Top companies in LOF
| Company | 510(k)s | Recalls |
|---|---|---|
| EBI, LLC | 0 | 4 |
| Bioventus, LLC | 0 | 1 |
| Djo, LLC | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 23, 2024 | EBI, LLC 48" Lead Wires, Replacement
Part Number: 1067724-4 Open, Classified |
LOF | None listed |
| Apr 23, 2024 | EBI, LLC 20" Lead Wires, Replacement
Part Number: 1067724-2 Open, Classified |
LOF | None listed |
| Apr 23, 2024 | EBI, LLC Biomet OrthoPak Non-invasive Bone Growth Stimulator System-Indicated
for the treatment of an established nonunion acquired secondary to trauma,
excluding vertebrae and all flat bones.
Part Number: 106 Open, Classified |
LOF | None listed |
| Apr 23, 2024 | EBI, LLC Biomet SpinalPak Non-invasive Spine Fusion Stimulator System- Indicated
for the treatment of an established nonunion acquired secondary to trauma,
excluding vertebrae and all flat bones,
Part Number: Open, Classified |
LOF | None listed |
| Dec 17, 2020 | Bioventus, LLC EXOGEN Ultrasound Coupling Gel Terminated |
LOF | None listed |
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