BONE SOURCE HAC RAPID SETTING CEMENT— 510(k) K043334

Name: FDA 510(k) clearance K043334
Creator: U.S. Food and Drug Administration
Published: 2005-02-09

Substantially Equivalent

Stryker Instruments

FDA 510(k) clearance K043334 for BONE SOURCE HAC RAPID SETTING CEMENT, Substantially Equivalent on 2005-02-09. Applicant: Stryker Instruments. Device class: 2.

Clearance details

Applicant: Stryker Instruments
Product code: Code GXP
Device class: Class 2
Regulation: 21 CFR 882.5300
Advisory panel: Neurology
Date received: 2004-12-03
Decision date: 2005-02-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Kalamazoo, MI, US

Download summary PDF View on FDA.gov ↗

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