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Wiltrom Spinal Fixation System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K172548

by Wiltrom Corporation Limited

Identifiers

510(k) Number
K172548 FDA 510(k)
FDA Product Code
NKB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 888.3070 FDA 510(k)
Regulation Number
888.3070 FDA 510(k)
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Wiltrom Spinal Fixation System is a spinal fixation system intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of thoracic, lumbar, and sacral spine instabilities or deformities. It is used to treat acute and chronic instabilities or deformities, including severe spondylolisthesis. The system is made of Ti-6Al-4V ELI material, which complies with ISO 5832-3 and ASTM F136 standards.

The Wiltrom Spinal Fixation System is provided nonsterile and is for single use only. The system is supplied in various sizes and configurations, including Polyaxial Pedicle Screw. It has received FDA 510K authorization, with a clearance type of Traditional and a decision code of SESE. The device has a unique identifier, with a Primary DI of 04719873024186.

Frequently asked questions

What is the Wiltrom Spinal Fixation System used for?

The Wiltrom Spinal Fixation System is used to treat acute and chronic instabilities or deformities, including severe spondylolisthesis, in the thoracic, lumbar, and sacral spine.

Is the Wiltrom Spinal Fixation System supplied sterile?

No, the Wiltrom Spinal Fixation System is provided nonsterile and is for single use only.

What materials are used to make the Wiltrom Spinal Fixation System?

The system is made of Ti-6Al-4V ELI material, which complies with ISO 5832-3 and ASTM F136 standards.

What sizes and configurations are available for the Wiltrom Spinal Fixation System?

The system is supplied in various sizes and configurations, including Polyaxial Pedicle Screw.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: About Wiltrom - 台灣微創醫療器材股份有限公司, Wiltrom Spinal Fixation System (K202894) — FDA 510 (k) | Innolitics, Wiltrom Spinal Fixation System 43547560 Polyaxial Pedicle Screw ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Wiltrom Corporation Limited

Sources (1)

  • FDA 510(k) K172548 24 fields · synced Sep 27, 2026