MIX EVAC II— 510(k) K854077

Name: FDA 510(k) clearance K854077
Creator: U.S. Food and Drug Administration
Published: 1986-01-31

Substantially Equivalent for Some Indications

Stryker Corp.

FDA 510(k) clearance K854077 for MIX EVAC II, Substantially Equivalent for Some Indications on 1986-01-31. 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: 1985-10-07
Decision date: 1986-01-31
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Kalamazoo, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JDZ

view all

K934253 — EXACTECH ALL POLY ACETABULAR CUP1994-04-29
K925025 — PRISM BONE CEMENT MIXING SYSTEM1994-01-05
K912190 — STRYKER HIGH VACUUM BONE CEMENT MIXER/INJECT SYST1991-08-29
K892937 — REUSABLE BOWL AND SPATULA FOR MIXING BONE CEMENTS1989-06-22
K861086 — ZIMMER VACUUM MIXING SYSTEM1986-04-14

More clearances from Stryker Corp.

view all

K230045 — HipCheck2023-09-29
K191259 — Stryker CrossFlow Integrated Arthroscopy Pump2019-07-12
K182359 — HipCheck2018-12-13
K143399 — Stryker Footed Attachments and Cutting Accessories2015-05-08
K143320 — Stryker Elite Attachments, Stryker Heavy Duty (HD) Attachments2015-04-23

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.