Skip to content

NuVasive Reline System

by Nu Vasive, Incorporated 2 variants

510(k) K161014

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 NumberK161014 Date28 Sep 2016ClearedStatusActive

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  • Withdrawn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
NKB
Device Class
Class II
Regulation
21 CFR Part 888.3070
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Reline System is a posterior spinal fixation device designed for orthopedic surgical applications. It is classified as a spinal fixation system, intended for use in procedures requiring three-dimensional correction of spinal deformities, such as scoliosis.

The system is supplied as a reusable medical device and is intended for use in sterile surgical environments. It is regulated under FDA 510(k) clearance (K161014) and falls under the orthopedic advisory committee category. No specific MRI safety information is provided in the available data.

Other devices from Nu Vasive, Incorporated

See all devices from Nu Vasive, Incorporated →

Questions

AI-generated answers, 19 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 types of spinal procedures is the NuVasive Reline System designed for, and why is it considered a posterior fixation device?

    The NuVasive Reline System is specifically designed for posterior spinal fixation procedures that require three-dimensional correction of spinal deformities, such as scoliosis. It is classified as a posterior spinal fixation device because it is intended to be applied to the back (posterior) side of the spine, providing stability and alignment through surgical instrumentation.

  • Is the NuVasive Reline System intended for single-use or reusable applications, and how does this affect its use in surgery?

    The NuVasive Reline System is explicitly described as a reusable medical device. This means it is engineered to withstand multiple surgical procedures under strict sterilization protocols, ensuring cost efficiency for facilities while maintaining safety standards for sterile surgical environments.

  • How is the NuVasive Reline System regulated, and what does the FDA’s 510(k) clearance (K161014) indicate about its approval process?

    The NuVasive Reline System is regulated under the FDA’s 510(k) clearance pathway, specifically granted under clearance number K161014. This indicates that the device was determined to be substantially equivalent to a legally marketed predicate device, meaning it meets FDA requirements for safety and effectiveness based on comparative data rather than a full de novo review.

  • What kind of surgical environment is the NuVasive Reline System intended for, and why is this important?

    The NuVasive Reline System is intended exclusively for sterile surgical environments, as it is a reusable device requiring rigorous cleaning and sterilization between uses. This ensures patient safety by preventing contamination and infection during spinal fixation procedures.