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Pss System

by Spinal USA 2 variants

510(k) K071438

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 NumberK071438 Date21 Aug 2007ClearedStatusActive

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  • Withdrawn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
MNI
Device Class
Class II
Regulation
21 CFR Part 888.3070
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 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 Pss System is a spinal immobilization and stabilization device intended to provide adjunctive support to fusion in the treatment of thoracic, lumbar, and sacral spine instabilities or deformities. It is designed for use in skeletally mature patients. The device is used to treat various conditions, including degenerative spondylolisthesis, fracture, dislocation, and scoliosis. The Pss System is classified under the product code MNI.

The Pss System is supplied as a traditional clearance type device, with FDA 510(k) authorization under the k number K071438. The device is manufactured by Spinal USA, and its use is supported by a surgical technique guide. The system is intended for single use, although the data does not explicitly state this; it does, however, provide information on its intended use and the conditions it is designed to treat. The device is available for use in medical settings, with its specifications and authorizations supporting its safe and effective use.

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Questions

AI-generated answers, 25 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 PSS System used for?

    The PSS System is used to provide adjunctive support to fusion in the treatment of thoracic, lumbar, and sacral spine instabilities or deformities, including conditions such as degenerative spondylolisthesis, fracture, dislocation, and scoliosis.

  • Is the PSS System intended for single use?

    Although not explicitly stated, the PSS System is intended for use in medical settings and its specifications and authorizations support its safe and effective use, suggesting single use.

  • What is the regulatory status of the PSS System?

    The PSS System has FDA 510(k) authorization under the k number K071438, indicating it has been cleared for use as a substantially equivalent device.

  • What type of patients is the PSS System designed for?

    The PSS System is designed for use in skeletally mature patients, indicating it is intended for adult patients with fully developed skeletons.