Identity
- Trade Name
- VIA Spinous Process Fixation System FDA UDI
- Generic Name
- Spinal implant trial FDA UDI
- Device Name
- 11mm Trial FDA UDI
- Model / Reference
- 34-03-01-2 FDA UDI
- Description
- 11mm Trial FDA UDI
Identifiers
- Catalog Number
- 440-0012 FDA UDI
- Primary DI / UDI-DI
- M7404400012 FDA UDI
- 510(k) Number
- K142213 FDA UDI
- FDA Product Code
- PEK FDA UDI
- GMDN Term
- Spinal implant trial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3050 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
MR Unsafe FDA UDI
Dimensions & Sizes
- Size
- Length — 11 Millimeter FDA UDI
Category: Spinal implant trial
VIA Spinous Process Fixation System by Spineology Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K142213 also covers:
- VIA Spinous Process Fixation System — SPINEOLOGY INC.
- VIA Spinous Process Fixation System — SPINEOLOGY INC.
- VIA Spinous Process Fixation System — SPINEOLOGY INC.
- VIA Spinous Process Fixation System — SPINEOLOGY INC.
- VIA Spinous Process Fixation System — SPINEOLOGY INC.
- VIA Spinous Process Fixation System — SPINEOLOGY INC.
- VIA Spinous Process Fixation System — SPINEOLOGY INC.
- VIA Spinous Process Fixation System — SPINEOLOGY INC.
- VIA Spinous Process Fixation System — SPINEOLOGY INC.
- VIA Spinous Process Fixation System — SPINEOLOGY INC.
- VIA Spinous Process Fixation System — SPINEOLOGY INC.
- VIA Spinous Process Fixation System — SPINEOLOGY 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 II | Pending data |
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Manufacturer
- Manufacturer
- Spineology Inc.
Sources (1)
- FDA UDI 2a6121b0-6c78-409b-8695-d882439220dd 37 fields · synced May 30, 2026