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Plateau Spacer System

by Life Spine 4 variants

510(k) K121116

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 NumberK121116 Date8 May 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  • Withdrawn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
MAX
Device class
Class II
Regulation
21 CFR Part 888.3080
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 Plateau Spacer System is an orthopedic interbody fusion device designed for spinal reconstruction. It consists of polyetheretherketone (PEEK) spacers intended to maintain disc space height and promote spinal fusion during posterior or transforaminal lumbar procedures. The device is categorized under orthopedic implants and is engineered to restore sagittal alignment and structural integrity in the lumbar spine.

The system is supplied as a sterile, single-use device and is available in multiple footprint sizes and heights to accommodate varying patient anatomies and pathologies. It is intended for use in surgical settings and has received FDA 510(k) clearance under the Special 510(k) program, classified under the Orthopedic advisory committee. Storage and handling must comply with sterile medical device protocols to ensure integrity prior to surgical use.

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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 Plateau Spacer System used for?

    The Plateau Spacer System is designed for spinal reconstruction in the lumbar region, specifically to maintain disc space height and facilitate spinal fusion during posterior or transforaminal lumbar procedures. It helps restore sagittal alignment and structural integrity, addressing degenerative conditions or anatomical defects requiring stabilization.

  • How is the Plateau Spacer System supplied and what are its key features?

    The system is supplied as a sterile, single-use device, ensuring surgical safety and compliance with medical device protocols. It is made from polyetheretherketone (PEEK), a biocompatible material chosen for its strength and radiolucency. The device comes in multiple footprint sizes and heights to match diverse patient anatomies and pathologies, allowing surgeons to select the optimal fit for each case.

  • Is the Plateau Spacer System reusable or intended for single-use?

    The Plateau Spacer System is explicitly designed for single-use only. This classification aligns with sterile medical device standards to prevent contamination and ensure patient safety. Reuse is not recommended or supported by the manufacturer.

  • What storage and handling precautions must be followed for the Plateau Spacer System?

    The device must be stored and handled according to sterile medical device protocols to preserve its integrity before surgical use. This includes maintaining proper packaging, avoiding exposure to moisture or contaminants, and adhering to manufacturer guidelines for shelf life and environmental conditions. Improper storage could compromise sterility or functionality.

  • What regulatory pathway does the Plateau Spacer System follow?

    The Plateau Spacer System has received FDA 510(k) clearance under the Special 510(k) program, classified under the Orthopedic advisory committee. This pathway confirms that the device is deemed substantially equivalent to a legally marketed predicate device, ensuring it meets regulatory standards for safety and effectiveness in its intended use.