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Surgical Simplex P Radiopaque Bone Cement and Acm and Mixevacii

by Stryker Corp.

510(k) K002652

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 NumberK002652 Date26 Jan 2001ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0736-2023 FDA Class III initiated 7 Nov 2022

    Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish language. Although the Turkish translation is missing, all content within the IFUs is accurate.

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  • Withdrawn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

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