Identity
- Trade Name
- Retropsoas Electrode FDA UDI
- Generic Name
- General internal orthopaedic fixation system implantation kit FDA UDI
- Device Name
- Retropsoas Electrode, NERVE CUFF TRIAL SIZER, 8/10MM. The EARP Nerve Cuff Electrode is used to perform localized stimulation of neural tissue and to locate, identify, and monitor spinal nerve roots during surgery. FDA UDI
- Model / Reference
- ELEC2280 FDA UDI
- Description
- Retropsoas Electrode, NERVE CUFF TRIAL SIZER, 8/10MM. The EARP Nerve Cuff Electrode is used to perform localized stimulation of neural tissue and to locate, identify, and monitor spinal nerve roots during surgery. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810135960564 FDA UDI
- 510(k) Number
- K230853 FDA UDI
- FDA Product Code
- MDM FDA UDI
- GMDN Term
- General internal orthopaedic fixation system implantation kit FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4800 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: General internal orthopaedic fixation system implantation kit
Retropsoas Electrode by Nvision Biomedical Technologies, Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K230853 also covers:
- Retropsoas Electrode — NVISION BIOMEDICAL TECHNOLOGIES, INC
- Retropsoas Electrode — NVISION BIOMEDICAL TECHNOLOGIES, INC
- Retropsoas Electrode — NVISION BIOMEDICAL TECHNOLOGIES, INC
- Retropsoas Electrode — NVISION BIOMEDICAL TECHNOLOGIES, INC
- Retropsoas Electrode — NVISION BIOMEDICAL TECHNOLOGIES, INC
- Retropsoas Electrode — NVISION BIOMEDICAL TECHNOLOGIES, INC
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 I | Pending data |
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Manufacturer
- Manufacturer
- Nvision Biomedical Technologies, Inc
Sources (1)
- FDA UDI ebee61ae-3202-4842-b207-4e431d1609fc 35 fields · synced May 30, 2026