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NuVasive Camber Laminoplasty System

by Nu Vasive, Incorporated

510(k) K191169

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 NumberK191169 Date3 Jul 2019ClearedStatusActive

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  • Withdrawn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, 26 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 Camber Laminoplasty System is a metal spinal orthosis consisting of plates and screws. It is designed to provide reinforcement while expanding the spinal canal and preserving posterior elements during laminoplasty procedures.

The system includes titanium alloy components and associated surgical instruments. It is used to secure allograft or autograft material to prevent graft expulsion or spinal cord impingement. This device received FDA 510(k) clearance under K191169.

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