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NP Cement HV;NP Cement LV; NP Cement HV System; NP Cement LV System

by Cossington, Ltd.

510(k) K143134

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 NumberK143134 Date5 Mar 2015ClearedStatusActive

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  • Withdrawn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
LOD
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 888.3027
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 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 NP Cement HV and NP Cement LV systems are bone cements classified as orthopedic medical devices. These products are intended to be used for the fixation of artificial joint prostheses to the host bone.

This device is subject to FDA 510(k) clearance under regulation number 888.3027. It is categorized as an FDA class 2 device and is intended for use in orthopedic procedures.

Other devices from Cossington, Ltd.

Questions

AI-generated answers, 26 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 intended use of the NP Cement HV and LV systems?

    These products are classified as orthopedic medical devices intended for the fixation of artificial joint prostheses to the host bone.

  • What is the regulatory status of these bone cement systems?

    The NP Cement HV and LV systems have received FDA 510(k) clearance under regulation number 888.3027 and are categorized as FDA class 2 devices.

  • Which medical specialty uses these devices?

    These devices are intended for use in orthopedic procedures, as indicated by their classification under the orthopedic advisory committee.