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NuVasive BASE Interfixated Titanium System

by Nu Vasive, Incorporated

510(k) K170592

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 NumberK170592 Date26 Apr 2017ClearedStatusActive

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  • Withdrawn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
OVD
Device Class
Class II
Regulation
21 CFR Part 888.3080
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 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 BASE Interfixated Titanium System is a spinal implant system intended for use in spinal fusion procedures. It is designed to provide stabilization and support in the treatment of spinal conditions requiring interbody fusion.

The system is supplied as a non-sterile, reusable implant system and is indicated for use in patients requiring spinal fusion. It is not MRI safe unless otherwise specified, and its use is restricted to trained medical professionals in a hospital or surgical setting. The device received FDA 510(k) clearance under K170592 and is classified under product code OVD.

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Questions

AI-generated answers, 1 Oct 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 BASE Interfixated Titanium System used for?

    The NuVasive BASE Interfixated Titanium System is intended for use in spinal fusion procedures to provide stabilization and support in the treatment of spinal conditions requiring interbody fusion, as it is designed specifically for this clinical application.

  • How is the NuVasive BASE Interfixated Titanium System supplied and is it sterile or reusable?

    The system is supplied as a non-sterile, reusable implant system, meaning it must be sterilized by the user before each use and can be reprocessed for multiple procedures following appropriate cleaning and sterilization protocols.

  • Who is authorized to use the NuVasive BASE Interfixated Titanium System and in what setting?

    The device is restricted to trained medical professionals and must be used in a hospital or surgical setting, as its use requires specialized expertise and controlled environmental conditions to ensure patient safety and proper implantation.

  • What regulatory pathway was used for the NuVasive BASE Interfixated Titanium System and what is its product code?

    The device received FDA 510(k) clearance under K170592 and is classified under product code OVD, indicating it was found substantially equivalent to a legally marketed predicate device through the traditional 510(k) review process.