Orthofix Osteogenesis Stimulator
Cervical-Stim Osteogenesis Stimulator, Demo
1manufacturer
16catalogue numbers in this listing
Who Else Makes It
Registered in Guangdong. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| JKH Health Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 22 |
Record
| Listed by | Orthofix US LLC, United States |
|---|---|
| FDA product code | LOF |
| Device type | Stimulator, Bone Growth, Non-Invasive |
| Device class | Class 2 |
| Regulation | 21 CFR 890.5870 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | P850007 |
| Record published | 2015-05-12 |
| Record revised | 2026-02-20 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment temperature -10 to 45 °C |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3314R | In distribution | |
| 3315D | In distribution | |
| 3313 | In distribution | |
| 3314L | In distribution | |
| 3314LD | In distribution | |
| 3303 | In distribution | |
| 3202 | In distribution | |
| 3303D | In distribution | |
| 3314RD | In distribution | |
| 2505 | In distribution | |
| 3315 | In distribution | |
| 2212D | In distribution | |
| 2212 | In distribution | |
| 3202D | In distribution | |
| 3313D | In distribution | |
| 2505D | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Pemf – Physio-Stim | Orthofix US LLC | 39 |
| Physio-Stim | Orthofix US LLC | 26 |
| Biomet EBI Bone Healing System | EBI, LLC | 24 |
| Biomet SpinalPak / OrthoPak | EBI, LLC | 18 |
| Xstim | Xstim Inc. | 11 |
| ActaStim-S | Theragen, Inc. | 11 |
| CMF | DJO, LLC | 8 |
| Biomet SpinalPak Non-invasive Spine Fusion Stimulator System | EBI, LLC | 7 |
| Cervical-Stim | Orthofix US LLC | 7 |
| Biomet OrthoPak Non-invasive Bone Growth Stimulator System | EBI, LLC | 6 |
| Accelstim | Igea SPA | 6 |
| Spinal Stim | Orthofix US LLC | 6 |
Showing 12 of 21. All products under Stimulator, Bone Growth, Non-Invasive
PMA Approvals
A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.
| PMA number | Decision | Trade name | Approved to |
|---|---|---|---|
| P210016 | 2025-01-17 | ManaFuse | Enovis |
| P230025 | 2024-11-12 | Xstim Spine Fusion Stimulator | Xstim Inc. |
| P790002 | 2022-11-23 | Biomet® OrthoPak Non-invasive Bone Growth Stimulator System | Ahp Eos Buyer, Inc. |
| P190030 | 2022-06-17 | ActaStim-S Spine Fusion Stimulator | Theragen, Inc. |
| P210035 | 2022-05-03 | AccelStimTM Bone Growth Stimulator | Orthofix US LLC |
| P850007 | 2018-08-22 | PhysioStim, SpinalStim | Orthofix SRL |
| P900009 | 2017-09-11 | EXOGEN Ultrasound Bone Healing System | Bioventus LLC |
| P850022 | 2015-09-09 | BIOMET SPINALPAK NON-INVASIVE SPINE FUSION STIMULATORY SYSTEM AND BIOMET ORTHOPAK NON-INVASIVE BONE GROWTH STIMULATOR | Ahp Eos Buyer, Inc. |
| P030034 | 2009-09-11 | CERVICAL-STIM | Orthofix SRL |
| P910066 | 1997-01-03 | ORTHOLOGIC (TM)1000 BONE GROWTH STIMULATOR | DJO, LLC |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.