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Prosthetic Cement Remover

by Albert K. Chin

510(k) K890285

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 NumberK890285 Date19 Apr 1989ClearedStatusActive

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  • Withdrawn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
LZV
Device Class
Class II
Regulation
21 CFR Part 888.4580
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 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 Prosthetic Cement Remover is a device used for cement removal extraction in orthopedic procedures. It is classified as a system for cement removal extraction and is used in the medical specialty of orthopedics.

The device is supplied with a product code of LZV and is regulated under the regulation number 888.4580. It has been authorized with FDA 510(k) clearance, with a decision description of Substantially Equivalent. The device is a class 2 device, with a traditional clearance type, and was decided on April 19, 1989.

Questions

AI-generated answers, 24 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 Prosthetic Cement Remover used for?

    The Prosthetic Cement Remover is used for cement removal extraction in orthopedic procedures, specifically in the medical specialty of orthopedics.

  • What regulatory authorization has the device received?

    The Prosthetic Cement Remover has received FDA 510(k) clearance, with a decision description of Substantially Equivalent, indicating it is substantially equivalent to a predicate device.

  • How is the device classified and regulated?

    The Prosthetic Cement Remover is classified as a class 2 device and is regulated under the regulation number 888.4580, with a product code of LZV.