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INNOVERSE Spinal System

by Innosys Co., Ltd.

510(k) K233960

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 NumberK233960 Date6 Feb 2024ClearedStatusActive

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  • Withdrawn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, 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 INNOVERSE Spinal System is a posterior, noncervical pedicle fixation system intended to provide immobilization and stabilization of spinal segments in skeletally-mature patients as an adjunct to fusion by autogenous bone graft. It is a top-loading multiple component system consisting of pedicle screws, rods, set screws, connectors, and cross links.

Implant components are available in a variety of sizes and can be rigidly locked into various configurations. The system is supplied non-sterile and requires sterilization prior to use. It is intended for single-use implantation and is regulated under FDA 510(k) clearance K233960 with product code NKB.

Other devices from Innosys Co., Ltd.

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 INNOVERSE Spinal System used for?

    The INNOVERSE Spinal System is intended to provide immobilization and stabilization of spinal segments in skeletally-mature patients as an adjunct to fusion by autogenous bone graft. It is a posterior, noncervical pedicle fixation system designed for spinal segment stabilization during fusion procedures.

  • How is the INNOVERSE Spinal System supplied and prepared for use?

    The system is supplied non-sterile and requires sterilization prior to use. It is intended for single-use implantation, meaning each component should be used only once and then discarded after implantation to ensure patient safety and device integrity.

  • What components are included in the INNOVERSE Spinal System?

    The INNOVERSE Spinal System is a top-loading multiple component system consisting of pedicle screws, rods, set screws, connectors, and cross links. Implant components are available in a variety of sizes and can be rigidly locked into various configurations to accommodate different anatomical needs and surgical techniques.

  • What regulatory pathway was used for the INNOVERSE Spinal System?

    The INNOVERSE Spinal System is regulated under FDA 510(k) clearance K233960 with product code NKB. It was determined to be substantially equivalent to a predicate device through the traditional 510(k) review process, as indicated by the decision code SESE and decision description 'Substantially Equivalent'.