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Laminoplasty Fixation System

by Nuvasive, Inc.

510(k) K091623

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 NumberK091623 Date9 Oct 2009ClearedStatusActive

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  • Withdrawn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
NQW
Device class
Class II
Regulation
21 CFR Part 888.3050
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 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 Laminoplasty Fixation System is an orthopedic device used in spine surgery. It is intended for use in the lower cervical and upper thoracic spine (C3 to T3) in laminoplasty procedures to hold allograft material in place and prevent expulsion or impingement of the spinal cord.

The device is supplied non-sterile and is classified as a Class II medical device under FDA regulation number 888.3050. It received traditional 510(k) clearance (K091623) and is substantially equivalent to a predicate device. The system is manufactured by Nuvasive, Inc. and is used in surgical settings for spinal fixation during laminoplasty.

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Questions

AI-generated answers, 28 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 Laminoplasty Fixation System used for?

    The Laminoplasty Fixation System is used in spine surgery to hold allograft material in place during laminoplasty procedures in the lower cervical and upper thoracic spine (C3 to T3), preventing expulsion or impingement of the spinal cord.

  • Is the Laminoplasty Fixation System sterile when supplied?

    The device is supplied non-sterile, meaning it must be sterilized by the user before surgical use, as indicated in the device specifications.

  • What regulatory pathway was used for the Laminoplasty Fixation System?

    The device received traditional 510(k) clearance (K091623) and is classified as a Class II medical device under FDA regulation number 888.3050, based on substantial equivalence to a predicate device.