Identity
- Trade Name
- VIA Spinous Process Fixation System FDA UDI
- Generic Name
- Surgical instrument handle, torque-limiting FDA UDI
- Device Name
- Final Tightner FDA UDI
- Model / Reference
- 10-46-03 FDA UDI
- Description
- Final Tightner FDA UDI
Identifiers
- Catalog Number
- 440-0030 FDA UDI
- Primary DI / UDI-DI
- M7404400030 FDA UDI
- 510(k) Number
- K142213 FDA UDI
- FDA Product Code
- PEK FDA UDI
- GMDN Term
- Surgical instrument handle, torque-limiting 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
MR Unsafe FDA UDI
Category: Surgical instrument handle, torque-limiting
VIA Spinous Process Fixation System by Spineology Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical instrument handle, torque-limiting.
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- KONG-TL VBR System, Torque Limiter with Coupling, 1/4'' Coupling, 1 Nm — Icotec · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Spineology Inc.
Sources (1)
- FDA UDI f2833634-474f-4738-8461-ce6e4c852f72 36 fields · synced May 31, 2026