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Tri-Fix Spinal Fixation System

by Endius, Inc. 5 variants

510(k) K000766

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK000766 Date1 Jun 2000ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MNI
Device Class
Class II
Regulation
21 CFR Part 888.3070
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Tri-Fix Spinal Fixation System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of various spinal instabilities or deformities. It is designed for use in the thoracic, lumbar, and sacral spine. The system is used to treat conditions such as degenerative spondylolisthesis. The device is a type of spinal fixation system, which is classified under the product code MNI.

The Tri-Fix Spinal Fixation System is supplied by Endius, Inc. and has received FDA 510(k) clearance, indicated by the clearance number K000766. The device is used in orthopedic applications and is regulated by the FDA. The system is designed for use in a clinical setting and is intended to be used by medical professionals. The device is available with the specified clearance number and is manufactured by Endius, Inc.

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Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Tri-Fix Spinal Fixation System used for?

    The Tri-Fix Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of various spinal instabilities or deformities, including degenerative spondylolisthesis, and is designed for use in the thoracic, lumbar, and sacral spine.

  • How is the Tri-Fix Spinal Fixation System supplied and by whom?

    The Tri-Fix Spinal Fixation System is supplied by Endius, Inc., the manufacturer, and is available with FDA 510(k) clearance number K000766 for use in clinical settings by medical professionals.

  • Is the Tri-Fix Spinal Fixation System reusable or single-use?

    The device data does not specify whether the Tri-Fix Spinal Fixation System is reusable or single-use; therefore, no determination about reusability can be made from the provided information.