DirectInject— 510(k) K143661

Substantially Equivalent

Stryker

FDA 510(k) clearance K143661 for DirectInject, Substantially Equivalent on 2015-09-02. Applicant: Stryker. Device class: 2.

Clearance details

Applicant: Stryker
Product code: Code GXP
Device class: Class 2
Regulation: 21 CFR 882.5300
Advisory panel: Neurology
Date received: 2014-12-23
Decision date: 2015-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portage, MI, US

Download summary PDF View on FDA.gov ↗

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More clearances from Stryker

Recalls naming K143661

K-number listed on FDA's recall record

Z-1436-2021 — DirectInject consists of a sterile dual paste system which is calcium phosphate based. Upon injection through the Mixer-Cannula, the two pastes form a cement paste which is moldable. The injected cement paste will harden under normal body conditions to form hydroxyapatite.Class II·Terminated·Stryker Leibinger GmbH & Co. KG·20210401

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K143661.

Data sourced from openFDA. This site is unofficial and independent of the FDA.