Skip to content

Laguna Polyaxial Pedicle Screw System

by Allez Spine, LLC

510(k) K083826

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 NumberK083826 Date22 Jan 2009ClearedStatusActive

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  • Withdrawn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
MNH
Device Class
Class II
Regulation
21 CFR Part 888.3070
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 Laguna Polyaxial Pedicle Screw System is a spinal fixation implant used to provide correction, immobilization, and stabilization of spinal segments as an adjunct to fusion. It consists of polyaxial screws in winged and non-winged configurations with lengths ranging from 35-100 mm and a diameter of 8 mm, along with 5.5 mm connecting rods.

The system is intended for posterior, non-cervical fixation in conditions such as degenerative disc disease, spondylolisthesis, trauma (fracture or dislocation), and spinal stenosis. It is assembled intraoperatively to create custom constructs. The device is authorized under FDA 510(k) clearance with K number K083826.

Other devices from Allez Spine, LLC

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 Laguna Polyaxial Pedicle Screw System used for?

    The Laguna Polyaxial Pedicle Screw System is a spinal fixation implant used to provide correction, immobilization, and stabilization of spinal segments as an adjunct to fusion in conditions such as degenerative disc disease, spondylolisthesis, trauma, and spinal stenosis.

  • What are the specifications of the Laguna Polyaxial Pedicle Screw System?

    The system consists of polyaxial screws in winged and non-winged configurations with lengths ranging from 35-100 mm and a diameter of 8 mm, along with 5.5 mm connecting rods. It is assembled intraoperatively to create custom constructs.

  • What is the regulatory status of the Laguna Polyaxial Pedicle Screw System?

    The device is authorized under FDA 510(k) clearance with K number K083826, which means it has been determined to be substantially equivalent to a predicate device already on the market.

  • How is the Laguna Polyaxial Pedicle Screw System supplied?

    The system is supplied as individual components including polyaxial screws in various configurations and lengths, along with connecting rods. These components are assembled intraoperatively by the surgeon to create custom spinal fixation constructs tailored to each patient's specific needs.