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Via Spinous Process Fixation System

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K142213

by Spineology Inc.

Identity

Trade Name
VIA Spinous Process Fixation System FDA UDI
Generic Name
Interspinous spinal fixation implant FDA UDI
Device Name
Male Plate FDA UDI
Model / Reference
34-01-03 FDA UDI
Description
Male Plate FDA UDI

Identifiers

Catalog Number
440-0003 FDA UDI
Primary DI / UDI-DI
M7404400003 FDA UDI
510(k) Number
K142213 FDA 510(k)FDA UDI
FDA Product Code
PEK FDA 510(k)FDA UDI
GMDN Term
Interspinous spinal fixation implant FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 888.3050 FDA 510(k)
Regulation Number
888.3050 FDA 510(k)FDA UDI
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

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
Sterilization Method
Ethylene Oxide FDA UDI
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Height — 13 Millimeter FDA UDI

Via Spinous Process Fixation System by Spineology Inc. — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Spineology Inc.
FDA Applicant
Spineology, Inc.

Sources (2)

  • FDA 510(k) K142213 24 fields · synced Jun 18, 2026
  • FDA UDI c1208d1e-cbc4-4805-9d9d-fb353681cf1a 37 fields · synced May 26, 2026