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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
Orthopaedic prosthesis implantation positioning instrument, single-use FDA UDI
Device Name
Guide Pin, 1.4mm x 508mm Round/Round FDA UDI
Model / Reference
53-01-032 FDA UDI
Description
Guide Pin, 1.4mm x 508mm Round/Round FDA UDI

Identifiers

Catalog Number
530-0087 FDA UDI
Primary DI / UDI-DI
M7405300087 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Orthopaedic prosthesis implantation positioning instrument, single-use 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

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Dimensions & Sizes

Size
Outer Diameter — 1.4 Micrometer FDA UDI
Length — 508 Millimeter FDA UDI

Category: Orthopaedic prosthesis implantation positioning instrument, single-use

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

Similar devices

Also classified as Orthopaedic prosthesis implantation positioning instrument, single-use.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Spineology Inc.

Sources (1)

  • FDA UDI d6b7c4a6-452f-4a3a-91e5-39dc4abd5370 36 fields · synced May 31, 2026