Product code LOF
- Device name
- Stimulator, Bone Growth, Non-Invasive
- 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 |
|---|---|---|---|
| P190030S004 | ActaStim-S | Theragen, Inc. | 2026-05-13 |
| P900009S050 | SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2A | Bioventus, LLC | 2026-03-06 |
| P210035S003 | AccelStim | Orthofix US, LLC | 2025-03-21 |
| P210016 | ManaFuse | Enovis | 2025-01-17 |
| P190030S003 | ActaStim-S Spine Fusion Stimulator | Theragen, Inc. | 2024-11-13 |
| P230025S001 | Xstim Spine Fusion Stimulator | Xstim, Inc. | 2024-11-12 |
| P210035S002 | AccelStim™ | Orthofix US, LLC | 2024-07-11 |
| P850022S034 | Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator System, Biomet® OrthoPak® Non-invasive Bone Growth Stimulator Sy | Ahp Eos Buyer, Inc. | 2024-02-29 |
| P230025 | Xstim Spine Fusion Stimulator | Xstim, Inc. | 2024-02-09 |
| P900009S049 | EXOGEN® Ultrasound Bone Healing System | Bioventus, LLC | 2023-12-21 |
| P850022S033 | Biomet® OrthoPak® Non-invasive Bone Growth Stimulator System & Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator S | Ahp Eos Buyer, Inc. | 2023-10-26 |
| P790002S039 | Biomet EBI Bone Healing System | Ahp Eos Buyer, Inc. | 2023-10-26 |
| P850022S032 | Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator System, Biomet® OrthoPak® Non-invasive Bone Growth Stimulator Sy | Ahp Eos Buyer, Inc. | 2023-09-01 |
| P190030S002 | ActaStim-S Non Invasive Spine Fusion Stimulator | Theragen, Inc. | 2023-03-23 |
| P850022S031 | Biomet® OrthoPak® Non-invasive Bone Growth Stimulator System and Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator | Ahp Eos Buyer, Inc. | 2022-11-23 |
| P790002S038 | Biomet® OrthoPak Non-invasive Bone Growth Stimulator System | Ahp Eos Buyer, Inc. | 2022-11-23 |
| P190030S001 | ActaStim-S Spine Fusion Stimulator | Theragen, Inc. | 2022-06-17 |
| P850007S046 | PhysioStim®, SpinalStim® | Orthofix, Inc. | 2022-06-14 |
| P030034S017 | CervicalStim® | Orthofix, Inc. | 2022-06-14 |
| P210035 | AccelStimTM Bone Growth Stimulator | Orthofix US, LLC | 2022-05-03 |
| P900009S048 | Exogen | Bioventus, LLC | 2022-01-07 |
| P900009S047 | EXOGEN Ultrasound Bone Healing System | Bioventus, LLC | 2021-08-31 |
| P900009S046 | EXOGEN Ultrasound Bone Healing System | Bioventus, LLC | 2021-04-14 |
| P190030 | ActaStim-S Spine Fusion Stimulator | Theragen, Inc. | 2020-12-09 |
| P850007S044 | SpinalStim | Orthofix, Inc. | 2020-03-27 |
| P910066S031 | CMF Bone Growth Stimulator (OL1000, OL1000 SC, and SpinaLogic) | Djo, LLC | 2020-01-23 |
| P900009S044 | Exogen Ultrasound Bone Healing System | Bioventus, LLC | 2019-12-20 |
| P850022S030 | Biomet OrthoPak Non-invasive Bone Growth Stimulator System and Biomet SpinalPak Non-invasive Spine Fusion Stimulator Sys | Ahp Eos Buyer, Inc. | 2019-12-03 |
| P850007S043 | PhysioStim and SpinalStim | Orthofix, Inc. | 2019-10-08 |
| P030034S015 | CervicalStim | Orthofix, Inc. | 2019-10-08 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00850047248107 | Xstim | Xstim, Inc | 2026-04-08 |
| 00850047248008 | Xstim | Xstim, Inc | 2024-08-16 |
| 10850047248005 | Xstim | Xstim, Inc | 2024-08-16 |
| 00850047248015 | Xstim | Xstim, Inc | 2024-08-16 |
| 00850047248022 | Xstim | Xstim, Inc | 2024-08-16 |
| 00850047248039 | Xstim | Xstim, Inc | 2024-08-16 |
| 00850047248046 | Xstim | Xstim, Inc | 2024-08-16 |
| 00850047248053 | Xstim | Xstim, Inc | 2024-08-16 |
| 00850047248060 | Xstim | Xstim, Inc | 2024-08-16 |
| 00850047248077 | Xstim | Xstim, Inc | 2024-08-16 |
| 00850047248084 | Xstim | Xstim, Inc | 2024-08-16 |
| 00850047248091 | Xstim | Xstim, Inc | 2024-08-16 |
| 18257200158720 | AccelStim | Orthofix US LLC | 2023-06-12 |
| 18257200158706 | AccelStim | Orthofix US LLC | 2023-06-12 |
| 18257200158713 | AccelStim | Orthofix US LLC | 2023-06-12 |
| 08050040997336 | Accelstim | IGEA SPA | 2022-11-04 |
| 08050040997329 | Accelstim | IGEA SPA | 2022-08-30 |
| 08050040997305 | Accelstim | IGEA SPA | 2022-08-30 |
| 08050040997312 | Accelstim | IGEA SPA | 2022-08-30 |
| 08050040997299 | Accelstim | IGEA SPA | 2022-08-30 |
| 08050040997213 | AccelStim | IGEA SPA | 2022-07-14 |
| M937710346601 | EXOGEN Metatarsal Strap | BIOVENTUS LLC | 2021-12-17 |
| 00850372007219 | ActaStim-S | THERAGEN, LLC | 2021-02-08 |
| 00850372007189 | ActaStim-S | THERAGEN, LLC | 2021-02-08 |
| 00850372007196 | ActaStim-S | THERAGEN, LLC | 2021-02-08 |
| 00850372007202 | ActaStim-S | THERAGEN, LLC | 2021-02-08 |
| 00850372007172 | ActaStim-S | THERAGEN, LLC | 2021-02-08 |
| 00850372007165 | ActaStim-S | THERAGEN, LLC | 2021-02-08 |
| M937710346011 | EXOGEN® Ultrasound Bone Healing System | BIOVENTUS LLC | 2017-01-12 |
| M937710344011 | EXOGEN® Ultrasound Bone Healing System MOU | BIOVENTUS LLC | 2017-01-12 |