Identity
- Trade Name
- ActaStim-S Spine Fusion Stimulator FDA PMA
- Generic Name
- Stimulator, bone growth, non-invasive FDA PMA
Identifiers
- PMA Number
- P190030 FDA PMA
- FDA Product Code
- LOF FDA PMA
Classification
- Device Class
- Class II FDA PMA
- Legislation / Framework
- 21 CFR Part 890.5870 FDA PMA
- Regulation Number
- 890.5870 FDA PMA
- Advisory Committee
- Orthopedic FDA PMA
- FDA Decision
- APRL FDA PMA
The ActaStim-S Spine Fusion Stimulator is a non-invasive bone growth stimulator (Device Class II) designed to accelerate bone healing. It delivers controlled electrical stimulation as an adjunct to primary lumbar spinal fusion surgery for one or two levels, promoting fusion in adult patients only. This device is classified under the generic name ‘Stimulator, bone growth, non-invasive’ and is intended for single-patient use in orthopedic applications.
The ActaStim-S is supplied as a single-use, prescription-only device and is regulated under FDA Premarket Approval (PMA P190030). It is not intended for MRI environments and must be stored according to manufacturer instructions. Authorized for use in adult patients undergoing lumbar spinal fusion, it adheres to regulatory requirements outlined in 21 CFR 890.5870 and is distributed exclusively through licensed healthcare providers.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P190030 | N/A | Active |
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Manufacturer
- Manufacturer
- Theragen, Inc.
Sources (1)
- FDA PMA P190030 24 fields · synced Sep 18, 2026