Identity
- Trade Name
- SpF®-PLUS-Mini (60 uA/M) FDA UDI
- Generic Name
- Patient-worn bone growth electromagnetic stimulator FDA UDI
- Device Name
- SPF-PLUS 60/M Implantable Spinal Fusion Stimulator FDA UDI
- Model / Reference
- 10-1398M FDA UDI
- Description
- SPF-PLUS 60/M Implantable Spinal Fusion Stimulator FDA UDI
Identifiers
- Catalog Number
- 10-1398M FDA UDI
- Primary DI / UDI-DI
- 00812301020126 FDA UDI
- PMA Number
- P850035 FDA UDI
- FDA Product Code
- LOE FDA UDI
- GMDN Term
- Patient-worn bone growth electromagnetic stimulator FDA UDI
Classification
- Device Class
- Class III FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Category: Patient-worn bone growth electromagnetic stimulator
SpF®-PLUS-Mini (60 uA/M) by Ebi, LLC — Class III — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Patient-worn bone growth electromagnetic stimulator.
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Cleared under the same submission
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 III | Pending data |
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Manufacturer
- Manufacturer
- Ebi, LLC
Sources (1)
- FDA UDI 409e3440-afc5-4742-8612-8f26be5e9b19 37 fields · synced May 30, 2026