Browse hierarchy: [Orthopedic (OR)](/submissions/OR) → [Subpart F — Physical Medicine Therapeutic Devices](/submissions/OR/subpart-f%E2%80%94physical-medicine-therapeutic-devices) → [21 CFR 890.5870](/submissions/OR/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5870) → LOF — Stimulator, Bone Growth, Non-Invasive

# LOF · Stimulator, Bone Growth, Non-Invasive

_Orthopedic · 21 CFR 890.5870 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/OR/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LOF

## Overview

- **Product Code:** LOF
- **Device Name:** Stimulator, Bone Growth, Non-Invasive
- **Regulation:** [21 CFR 890.5870](/submissions/OR/subpart-f%E2%80%94physical-medicine-therapeutic-devices/890.5870)
- **Device Class:** 2
- **Review Panel:** [Orthopedic](/submissions/OR)

## Recent Cleared Devices (10 of 10)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P210016](https://fda.innolitics.com/submissions/OR/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LOF/P210016.md) | ManaFuse | Enovis | Jan 17, 2025 | APPR |
| [P230025](https://fda.innolitics.com/submissions/OR/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LOF/P230025.md) | Xstim Spine Fusion Stimulator | Xstim, Inc. | Feb 9, 2024 | APPR |
| [P210035](https://fda.innolitics.com/submissions/OR/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LOF/P210035.md) | AccelStimTM Bone Growth Stimulator | Orthofix US, LLC | May 3, 2022 | APPR |
| [P190030](https://fda.innolitics.com/submissions/OR/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LOF/P190030.md) | ActaStim-S Spine Fusion Stimulator | Theragen, Inc. | Dec 9, 2020 | APPR |
| [P030034](https://fda.innolitics.com/submissions/OR/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LOF/P030034.md) | CERVICAL-STIM MODEL 505L CERVICAL FUSION SYSTEM | Orthofix, Inc. | Dec 23, 2004 | APPR |
| [P900009](https://fda.innolitics.com/submissions/OR/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LOF/P900009.md) | SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2A | Bioventus, LLC | Oct 5, 1994 | APPR |
| [P910066](https://fda.innolitics.com/submissions/OR/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LOF/P910066.md) | ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR | Djo, LLC | Mar 4, 1994 | APPR |
| [P850007](https://fda.innolitics.com/submissions/OR/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LOF/P850007.md) | PHYSIO-STIM(TM) I & II MODEL 6000 & 7000 | Orthofix, Inc. | Feb 21, 1986 | APPR |
| [P850022](https://fda.innolitics.com/submissions/OR/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LOF/P850022.md) | 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](https://fda.innolitics.com/submissions/OR/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LOF/P790002.md) | 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

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**Source:** [https://fda.innolitics.com/submissions/OR/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LOF](https://fda.innolitics.com/submissions/OR/subpart-f%E2%80%94physical-medicine-therapeutic-devices/LOF)

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