Skip to content

Jazz System

by Implanet, S.A. 4 variants

510(k) K121541

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 NumberK121541 Date13 Sep 2012ClearedStatusActive

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  • Withdrawn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
JDQ
Device Class
Class II
Regulation
21 CFR Part 888.3010
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 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 Jazz System is a hybrid posterior thoracolumbar fixation system designed for spinal surgery. It is intended for use in the treatment of spinal column disorders that require spinal fusion surgery.

This instrumentation is suitable for degenerative, trauma, and deformity surgery. The system has received FDA 510k clearance.

Other devices from Implanet, S.A.

See all devices from Implanet, S.A. →

Questions

AI-generated answers, 27 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 is the intended use of the Jazz System?

    The Jazz System is a hybrid posterior thoracolumbar fixation system designed to assist in spinal fusion surgery. It is indicated for the treatment of spinal column disorders, specifically covering cases related to degenerative conditions, trauma, and spinal deformities.

  • What is the regulatory status of this spinal fixation system?

    The Jazz System has received FDA 510k clearance, identified by k-number K121541. This indicates that the device has been found to be substantially equivalent to other legally marketed devices for the same intended use.

  • Which surgical applications is this instrumentation suitable for?

    This system is engineered for use in posterior thoracolumbar spinal surgery. It is versatile enough to be utilized by surgeons performing procedures for degenerative spinal disorders, trauma-related injuries, and the correction of spinal deformities.