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Trifix Spinal Fixation System

by Endius, Inc. 2 variants

510(k) K001627

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 · Special NumberK001627 Date3 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  • Withdrawn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
MNH
Device Class
Class II
Regulation
21 CFR Part 888.3070
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 Trifix Spinal Fixation System is a spinal fixation device intended for use in orthopedic applications. It is designed to provide stabilization and support to the spinal column during surgical procedures.

The system is supplied as a non-sterile, reusable device and is indicated for use in hospital or surgical settings. It has received FDA 510(k) clearance under product code MNH and was found substantially equivalent to a predicate device. The device is not MRI safe unless explicitly stated, and no specific sizes, storage conditions, or single-use claims are provided in the data.

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