LOF · Stimulator, Bone Growth, Non-Invasive
Orthopedic · 21 CFR 890.5870 · Class 2
Overview
| Product Code | LOF |
|---|---|
| Device Name | Stimulator, Bone Growth, Non-Invasive |
| Regulation | 21 CFR 890.5870 |
| Device Class | Class 2 |
| Review Panel | Orthopedic |
Recent Cleared Devices (10 of 10)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P210016 | ManaFuse | Enovis | Jan 17, 2025 | APPR |
| P230025 | Xstim Spine Fusion Stimulator | Xstim, Inc. | Feb 9, 2024 | APPR |
| P210035 | AccelStimTM Bone Growth Stimulator | Orthofix US, LLC | May 3, 2022 | APPR |
| P190030 | ActaStim-S Spine Fusion Stimulator | Theragen, Inc. | Dec 9, 2020 | APPR |
| P030034 | CERVICAL-STIM MODEL 505L CERVICAL FUSION SYSTEM | Orthofix, Inc. | Dec 23, 2004 | APPR |
| P900009 | SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2A | Bioventus, LLC | Oct 5, 1994 | APPR |
| P910066 | ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR | Djo, LLC | Mar 4, 1994 | APPR |
| P850007 | PHYSIO-STIM(TM) I & II MODEL 6000 & 7000 | Orthofix, Inc. | Feb 21, 1986 | APPR |
| P850022 | Biomet® OrthoPak® Non-invasive Bone Growth Stimulator System; Biomet® SpinalPak® Non-invasive Spine Fusion Stimulator Sy | Ahp Eos Buyer, Inc. | Feb 18, 1986 | APPR |
| P790002 | Biomet(R) EBI BONE Healing System | Ahp Eos Buyer, Inc. | Nov 6, 1979 | APPR |
Top Applicants
- Ahp Eos Buyer, Inc. — 2 clearances
- Orthofix, Inc. — 2 clearances
- Bioventus, LLC — 1 clearance
- Djo, LLC — 1 clearance
- Enovis — 1 clearance
