← Back to catalogue

Threshold V2 Pedicular Fixation System

FDA UDI

Class I (US FDA UDI)

by Spineology Inc.

Identity

Trade Name
Threshold V2 Pedicular Fixation System FDA UDI
Generic Name
Internal spinal fixation procedure kit, reusable FDA UDI
Device Name
Ø5.5mm x 200mm Rod Template FDA UDI
Model / Reference
10-46-29 FDA UDI
Description
Ø5.5mm x 200mm Rod Template FDA UDI

Identifiers

Catalog Number
900-0015 FDA UDI
Primary DI / UDI-DI
M7409000015 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Internal spinal fixation procedure kit, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 5.5 Millimeter FDA UDI
Length — 400 Millimeter FDA UDI

Category: Internal spinal fixation procedure kit, reusable

Threshold V2 Pedicular Fixation System by Spineology Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Internal spinal fixation procedure kit, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Spineology Inc.

Sources (1)

  • FDA UDI bc8048d9-5336-4cd4-a468-7a15a2e7ee32 36 fields · synced May 30, 2026