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NuVasive Anterior Cervical Plate Systems

by Nu Vasive, Incorporated

510(k) K212446

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 NumberK212446 Date3 Nov 2021ClearedStatusActive

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  • Withdrawn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, 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.

NuVasive Anterior Cervical Plate Systems are orthopedic devices intended for use in anterior cervical spine surgery. These systems are designed to provide stabilization and fixation of the cervical vertebrae following discectomy or corpectomy procedures.

The device is supplied non-sterile and is intended for single-use. It is manufactured by Nu Vasive, Incorporated and received FDA 510(k) clearance (K212446) on November 3, 2021, under product code KWQ. The system is used in hospital or surgical center settings by trained medical professionals.

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Questions

AI-generated answers, 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.

  • What is the NuVasive Anterior Cervical Plate System used for?

    The NuVasive Anterior Cervical Plate System is intended for use in anterior cervical spine surgery to provide stabilization and fixation of the cervical vertebrae following discectomy or corpectomy procedures, as stated in the device description.

  • Is the NuVasive Anterior Cervical Plate System supplied sterile or non-sterile, and is it for single-use or reuse?

    The device is supplied non-sterile and is intended for single-use only, as explicitly specified in the device data under the DESCRIPTION section.

  • Who manufactures the NuVasive Anterior Cervical Plate System and when did it receive FDA 510(k) clearance?

    The system is manufactured by Nu Vasive, Incorporated and received FDA 510(k) clearance (K212446) on November 3, 2021, under product code KWQ, as documented in the AUTHORIZATIONS and SPECIFICATIONS fields.