Identity
- Trade Name
- Spinal-Stim FDA UDI
- Generic Name
- Patient-worn bone growth electromagnetic stimulator FDA UDI
- Device Name
- Spinal-Stim Bone Growth Stimulator FDA UDI
- Model / Reference
- 2212DA FDA UDI
- Description
- Spinal-Stim Bone Growth Stimulator FDA UDI
Identifiers
- Primary DI / UDI-DI
- 18257200007127 FDA UDI
- PMA Number
- P850007 FDA UDI
- FDA Product Code
- LOF FDA UDI
- GMDN Term
- Patient-worn bone growth electromagnetic stimulator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 890.5870 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Patient-worn bone growth electromagnetic stimulator
Spinal-Stim by Orthofix US LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Patient-worn bone growth electromagnetic stimulator.
- ActaStim-S — Theragen, Inc. · Class III
- Biomet SpinalPak Non-invasive Spine Fusion Stimulator System — Ebi, LLC · Class III
- CMF — DJO, LLC · Class II
- Biomet SpinalPak Non-invasive Spine Fusion Stimulator System — Ebi, LLC · Class III
- Biomet SpinalPak / OrthoPak — Ebi, LLC · Class III
- Biomet SpinalPak / OrthoPak — Ebi, LLC · Class II
- Xstim — Xstim, Inc. · Class III
- Xstim — Xstim, Inc. · Class III
Cleared under the same submission
P850007 also covers:
- Orthofix Osteogenesis Stimulator — Orthofix US LLC
- Orthofix Osteogenesis Stimulator — Orthofix US LLC
- Orthofix Osteogenesis Stimulator — Orthofix US LLC
- Orthofix Osteogenesis Stimulator — Orthofix US LLC
- Orthofix Osteogenesis Stimulator — Orthofix US LLC
- Orthofix Osteogenesis Stimulator — Orthofix US LLC
- Orthofix Osteogenesis Stimulator — Orthofix US LLC
- Orthofix Osteogenesis Stimulator — Orthofix US LLC
- PEMF - PHYSIO-STIM — Orthofix US LLC
- PEMF - PHYSIO-STIM — Orthofix US LLC
- PEMF - PHYSIO-STIM — Orthofix US LLC
- PEMF - PHYSIO-STIM — Orthofix US LLC
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Orthofix US LLC
Sources (1)
- FDA UDI a635d7d0-d540-49b7-b4e5-e527512e8afa 36 fields · synced Jun 8, 2026