Home › Device types › LOE
Stimulator, Invasive Bone Growth
FDA product code LOE · Class 3 · Unknown
13
Registered devices
140
Adverse events
4
Recalls
0
510(k) clearances
Devices with this code
EBI OsteoGen™ Implantable Bone Growth Stimulator — EBI, LLCSpF®-PLUS-Mini (60 uA/W) — EBI, LLCEBI OsteoGen™ Implantable Bone Growth Stimulator — EBI, LLCSpF®-XL IIb Implantable Spinal Fusion Stimulator — EBI, LLCEBI OsteoGen™ Implantable Bone Growth Stimulator — EBI, LLCSpF®-PLUS-Mini (60 uA/M) — EBI, LLCEBI OsteoGen™ Implantable Bone Growth Stimulator — EBI, LLCEBI OsteoGen™ Implantable Bone Growth Stimulator — EBI, LLCSpF XL IIb Implantable Spinal Fusion Stimulator — EBI, LLCEBI OsteoGen™ Implantable Bone Growth Stimulator — EBI, LLCEBI OsteoGen™ Implantable Bone Growth Stimulator — EBI, LLCEBI OsteoGen™ Implantable Bone Growth Stimulator — EBI, LLCEBI OsteoGen Implantable Bone Growth Stimulator — EBI, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-02-19 | Zimmer Biomet, Inc. | Lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met. |
| 2018-02-19 | Zimmer Biomet, Inc. | Lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met. |
| 2017-04-20 | EBI Patient Care, Inc. | Zimmer Biomet is conducting a medical device field action for the SpF PLUS-Mini and SpF XL IIB Implantable Spinal Fusion Stimulator products due to higher than |
| 2017-04-20 | EBI Patient Care, Inc. | Zimmer Biomet is conducting a medical device field action for the SpF PLUS-Mini and SpF XL IIB Implantable Spinal Fusion Stimulator products due to higher than |
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