Identity
- Trade Name
- CMF FDA UDI
- Generic Name
- Patient-worn bone growth electromagnetic stimulator FDA UDI
- Device Name
- The SpinaLogic is a portable, battery powered, microcontrolled, noninvasive bone growth stimulator indicated as an adjunct electrical treatment to primary lumbar spinal fusion surgery for one or two levels. The SpinaLogic is available in one size. FDA UDI
- Model / Reference
- Spinalogic FDA UDI
- Description
- The SpinaLogic is a portable, battery powered, microcontrolled, noninvasive bone growth stimulator indicated as an adjunct electrical treatment to primary lumbar spinal fusion surgery for one or two levels. The SpinaLogic is available in one size. FDA UDI
Identifiers
- Catalog Number
- 01-207-0007 FDA UDI
- Primary DI / UDI-DI
- 00888912011495 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
No
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
Yes
FDA UDI
Category: Patient-worn bone growth electromagnetic stimulator
Cmf by Djo, 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
- Physio-Stim — Orthofix US LLC · Class II
- Biomet SpinalPak Non-invasive Spine Fusion Stimulator System — Ebi, LLC · Class III
- Spinal-Stim — Orthofix US 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
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
- Djo, Llc
Sources (1)
- FDA UDI 880c2eac-4320-460c-b0c1-f54f51c2f862 36 fields · synced Jun 6, 2026