Skip to content

NuVasive VersaTie System

by Nu Vasive, Incorporated

510(k) K161265

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 NumberK161265 Date15 Jul 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  • Withdrawn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
OWI
Device Class
Class II
Regulation
21 CFR Part 888.3010
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 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 VersaTie System is a temporary implant designed for use in orthopedic surgery. It provides temporary stabilization as a bone anchor during the development of solid bony fusion and aids in the repair of bone fractures.

The system is supplied as a posterior band system intended for primary and supplemental fixation in both adult and pediatric patients. It is intended for use in complex spinal pathologies where traditional fixation may not be feasible.

Other devices from Nu Vasive, Incorporated

See all devices from Nu Vasive, Incorporated →

Questions

AI-generated answers, 6 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 VersaTie System used for?

    This system is a temporary implant designed to provide stabilization during the development of solid bony fusion and to aid in the repair of bone fractures.

  • How is the VersaTie System supplied?

    It is supplied as a posterior band system intended for primary and supplemental fixation in both adult and pediatric patients.

  • What type of fixation does the system provide?

    It is intended for use in complex spinal pathologies where traditional fixation may not be feasible, serving as a temporary bone anchor.