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Altus Spine Pedicle Screw System

by Altus Partners, LLC 4 variants

510(k) K200322

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 NumberK200322 Date2 Jun 2020ClearedStatusActive

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  • Withdrawn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, 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 Altus Spine Pedicle Screw System is a pedicle screw system designed to provide immobilization of spinal segments in skeletally mature patients. It serves as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.

This system is intended for noncervical pedicle fixation for indications such as degenerative disc disease. The device is authorized under FDA 510(k) clearance K200322.

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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 intended use of the Altus Spine Pedicle Screw System?

    The Altus Spine Pedicle Screw System is designed to provide immobilization of spinal segments in skeletally mature patients. It acts as an adjunct to fusion for treating acute and chronic instabilities or deformities within the thoracic, lumbar, and sacral spine.

  • Which spinal conditions can be treated with this system?

    This system is indicated for noncervical pedicle fixation. It is specifically intended for use in patients suffering from conditions such as degenerative disc disease.

  • What is the regulatory status of this device?

    The Altus Spine Pedicle Screw System is authorized under FDA 510(k) clearance K200322, which was granted on June 2, 2020.