Product code LOE
- Device name
- Stimulator, Invasive Bone Growth
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- OR
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P850035S059 | SpF® Implantable Spinal Fusion Stimulators | Ahp Eos Buyer, Inc. | 2024-09-20 |
| P850035S058 | SpF® Implantable Spinal Fusion Stimulators | Ahp Eos Buyer, Inc. | 2022-11-23 |
| P790005S069 | EBI OsteoGen® Implantable Bone Growth Stimulators | Ahp Eos Buyer, Inc. | 2022-11-23 |
| P850035S057 | SpF Implantable Spinal Fusion Stimulators | Ahp Eos Buyer, Inc. | 2022-08-25 |
| P790005S068 | EBI OsteoGen™ Implantable Bone Growth Stimulators | Ahp Eos Buyer, Inc. | 2022-08-25 |
| P850035S056 | SpF Implantable Spinal Fusion Stimulators | Ahp Eos Buyer, Inc. | 2021-02-17 |
| P790005S067 | EBI OsteoGen Implantable Bone Growth Stimulators | Ahp Eos Buyer, Inc. | 2021-02-17 |
| P850035S054 | SpF Implantable Spinal Fusion Stimulators | Ahp Eos Buyer, Inc. | 2019-10-24 |
| P790005S065 | EBI OsteoGen Implantable Bone Growth Stimulators | Ahp Eos Buyer, Inc. | 2019-10-24 |
| P850035S055 | SpF Implantable Spinal Fusion Stimulators | Ahp Eos Buyer, Inc. | 2019-07-18 |
| P790005S066 | OsteoGen Surigically Implantable Bone Growth Stimulators | Ahp Eos Buyer, Inc. | 2019-07-18 |
| P850035S051 | SpF Implantable Spinal Fusion Stimulators | Ahp Eos Buyer, Inc. | 2018-11-02 |
| P790005S062 | EBI OsteoGen Implantable Bone Growth Stimulators | Ahp Eos Buyer, Inc. | 2018-11-02 |
| P850035S053 | SpF Implantable Spinal Fusion Stimulators | Ahp Eos Buyer, Inc. | 2018-05-07 |
| P790005S064 | EBI OsteoGen Implantable Bone Growth Stimulators | Ahp Eos Buyer, Inc. | 2018-05-07 |
| P850035S052 | SpF Implantable Spinal Fusion Stimulators | Ahp Eos Buyer, Inc. | 2018-05-04 |
| P790005S063 | EBI OsteoGen Impantable Bone Growth Stimulators | Ahp Eos Buyer, Inc. | 2018-05-04 |
| P850035S050 | SpF Implantable Spinal Fusion Stimulators | Ahp Eos Buyer, Inc. | 2018-04-26 |
| P790005S061 | EBI OsteoGen Implantable Bone Growth Stimulators | Ahp Eos Buyer, Inc. | 2018-04-26 |
| P850035S048 | SpF Implantable Spinal Fusion Stimulators | Ahp Eos Buyer, Inc. | 2018-03-30 |
| P790005S059 | EBI OsteoGen Implantable Bone Growth Stimulators | Ahp Eos Buyer, Inc. | 2018-03-30 |
| P850035S049 | SpF Implantable Spinal Fusion Stimulators | Ahp Eos Buyer, Inc. | 2018-03-29 |
| P790005S060 | EBI OsteoGen Implantable Bone Growth Stimulators | Ahp Eos Buyer, Inc. | 2018-03-29 |
| P850035S047 | SPF Implantable Spinal Fusion Stimulators | Ahp Eos Buyer, Inc. | 2018-03-14 |
| P850035S046 | SpF Implantable Spinal Fusion Stimulators | Ahp Eos Buyer, Inc. | 2018-03-14 |
| P790005S058 | EBI OsteoGen Implantable Bone Growth Stimulators | Ahp Eos Buyer, Inc. | 2018-03-14 |
| P790005S057 | EBI OsteoGen Implantable Bone Growth Stimulators | Ahp Eos Buyer, Inc. | 2018-03-14 |
| P850035S045 | SpF Implantable Spinal Fusion Stimulators | Ahp Eos Buyer, Inc. | 2017-06-02 |
| P790005S056 | EBI OsteoGen Implantable Bone Growth Stimulators | Ahp Eos Buyer, Inc. | 2017-06-02 |
| P850035S044 | SpF Implantable Spinal Fusion Stimulators | Ahp Eos Buyer, Inc. | 2017-03-27 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00812301020010 | EBI OsteoGen Implantable Bone Growth Stimulator | EBI, LLC | 2014-09-19 |
| 00812301020027 | EBI OsteoGen™ Implantable Bone Growth Stimulator | EBI, LLC | 2014-09-19 |
| 00812301020034 | EBI OsteoGen™ Implantable Bone Growth Stimulator | EBI, LLC | 2014-09-19 |
| 00812301020041 | EBI OsteoGen™ Implantable Bone Growth Stimulator | EBI, LLC | 2014-09-19 |
| 00812301020058 | EBI OsteoGen™ Implantable Bone Growth Stimulator | EBI, LLC | 2014-09-19 |
| 00812301020065 | EBI OsteoGen™ Implantable Bone Growth Stimulator | EBI, LLC | 2014-09-19 |
| 00812301020072 | EBI OsteoGen™ Implantable Bone Growth Stimulator | EBI, LLC | 2014-09-19 |
| 00812301020089 | SpF XL IIb Implantable Spinal Fusion Stimulator | EBI, LLC | 2014-09-19 |
| 00812301020096 | SpF®-XL IIb Implantable Spinal Fusion Stimulator | EBI, LLC | 2014-09-19 |
| 00812301020102 | EBI OsteoGen™ Implantable Bone Growth Stimulator | EBI, LLC | 2014-09-19 |
| 00812301020119 | EBI OsteoGen™ Implantable Bone Growth Stimulator | EBI, LLC | 2014-09-19 |
| 00812301020126 | SpF®-PLUS-Mini (60 uA/M) | EBI, LLC | 2014-09-19 |
| 00812301020133 | SpF®-PLUS-Mini (60 uA/W) | EBI, LLC | 2014-09-19 |