Skip to content

Blade Anterior Cervical Plate System

by Nexxt Medical, Inc.

510(k) K091936

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 NumberK091936 Date19 Jan 2010ClearedStatusActive

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  • Withdrawn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
KWQ
Device Class
Class II
Regulation
21 CFR Part 888.3060
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 Blade Anterior Cervical Plate System is designed to provide biomechanical stabilization as an adjunct to fusion in skeletally mature patients. It is used for anterior screw fixation in the development of cervical spine. The system is intended to offer spinal fixation.

The Blade Anterior Cervical Plate System is supplied with a low profile and oversized visualization windows. It is used by surgeons who have had hands-on training in spinal fixation and are knowledgeable about spinal anatomy and biomechanics. The system has received FDA 510K authorization.

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 Blade Anterior Cervical Plate System used for?

    The system is used for anterior screw fixation in the development of cervical spine to provide biomechanical stabilization as an adjunct to fusion in skeletally mature patients.

  • What kind of training is required to use the Blade Anterior Cervical Plate System?

    Surgeons using the system should have had hands-on training in spinal fixation and be knowledgeable about spinal anatomy and biomechanics.

  • What is the regulatory status of the Blade Anterior Cervical Plate System?

    The system has received FDA 510K authorization, indicating it is substantially equivalent to a predicate device.