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Endius Minit Posterior Cervical and Upper Thoracic Fixation System

by Endius, Inc. 3 variants

510(k) K060683

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 NumberK060683 Date18 Apr 2006ClearedStatusActive

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  • Withdrawn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
KWP
Device Class
Class II
Regulation
21 CFR Part 888.3050
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 Endius Minit Posterior Cervical and Upper Thoracic Fixation System is a posterior spinal fixation device designed to stabilize and promote fusion in the cervical and upper thoracic spine (C1-T3). It consists of rods, hooks, and screws that are manually assembled and locked by surgeons in an operating room setting.

The system is supplied as a sterile, single-use device and is intended for use in surgical procedures to support spinal fusion. It is not reusable and must be stored in a dry environment until use. The device is regulated under FDA 510(k) clearance (K060683) and has been reviewed by the Orthopedic Devices Advisory Committee.

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Questions

AI-generated answers, 27 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 Endius Minit system used for?

    The Endius Minit system is used to stabilize and promote fusion in the cervical and upper thoracic spine (C1-T3) during surgical procedures.

  • Is the Endius Minit system reusable?

    No, the Endius Minit system is not reusable and must be discarded after a single use.

  • How is the Endius Minit system stored?

    The Endius Minit system must be stored in a dry environment until use to maintain its sterility.