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Nuvasive Helix ACP System

by Nuvasive, Inc.

510(k) K071329

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 NumberK071329 Date8 Aug 2007ClearedStatusActive

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  • Withdrawn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, 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 Nuvasive Helix ACP System is an anterior cervical plating system consisting of various implant components, including plates and screws, along with associated manual general surgical instruments. It is intended for anterior screw fixation of the cervical spine to provide stabilization as an adjunct to cervical fusion.

This system is authorized via FDA 510K clearance. It is designed to accommodate natural anatomical settling through its implant features and locking mechanism. Users should refer to the specific instructions for use for details regarding clinical application and surgical handling.

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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 primary clinical purpose of the Nuvasive Helix ACP System?

    This system is intended for anterior screw fixation of the cervical spine. It serves as an adjunct to cervical fusion procedures to provide necessary stabilization to the spine.

  • What components are included in the Nuvasive Helix ACP System?

    The system consists of various implant components, specifically plates and screws, which are used in conjunction with associated manual general surgical instruments to perform the fixation procedure.

  • How does the system accommodate the patient's anatomy?

    The system is specifically designed to accommodate natural anatomical settling through its integrated implant features and locking mechanism, which helps maintain stability during the fusion process.

  • What is the regulatory status of this device?

    The Nuvasive Helix ACP System is authorized via FDA 510K clearance, under the K-number K071329, which indicates it has been found substantially equivalent to legally marketed predicate devices.