Threshold Pedicular Fixation System

FDA UDI

Class I (US FDA UDI)

by Spineology Inc.

Identity

Trade Name: Threshold Pedicular Fixation System FDA UDI
Generic Name: Laparoscopic access cannula dilator FDA UDI
Device Name: Dilator One FDA UDI
Model / Reference: 53-07-11 FDA UDI
Description: Dilator One FDA UDI

Identifiers

Catalog Number: 530-0012 FDA UDI
Primary DI / UDI-DI: M7405300012 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Laparoscopic access cannula dilator 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Laparoscopic access cannula dilator

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

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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: Spineology Inc.

Sources (1)

FDA UDI ce21049a-764a-45d9-afa6-d4c81cf74043 35 fields · synced May 30, 2026