STRYKER HIGH VACUUM BONE CEMENT MIXER/INJECT SYST— 510(k) K912190

Name: FDA 510(k) clearance K912190
Creator: U.S. Food and Drug Administration
Published: 1991-08-29

Substantially Equivalent

Stryker Corp.

FDA 510(k) clearance K912190 for STRYKER HIGH VACUUM BONE CEMENT MIXER/INJECT SYST, Substantially Equivalent on 1991-08-29. Applicant: Stryker Corp.. Device class: 1.

Clearance details

Applicant: Stryker Corp.
Product code: Code JDZ
Device class: Class 1
Regulation: 21 CFR 888.4210
Advisory panel: Orthopedic
Date received: 1991-05-17
Decision date: 1991-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kalamazoo, MI, US

Download summary PDF View on FDA.gov ↗

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K892937 — REUSABLE BOWL AND SPATULA FOR MIXING BONE CEMENTS1989-06-22
K861086 — ZIMMER VACUUM MIXING SYSTEM1986-04-14
K854077 — MIX EVAC II1986-01-31

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Adverse events under product code JDZ

product code JDZ

Malfunction: 461
Total: 461

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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