SIMPLEX ENHANCEMENT MIXER— 510(k) K853310

Name: FDA 510(k) clearance K853310
Creator: U.S. Food and Drug Administration
Published: 1985-09-11

Substantially Equivalent

Howmedica Corp.

FDA 510(k) clearance K853310 for SIMPLEX ENHANCEMENT MIXER, Substantially Equivalent on 1985-09-11. Applicant: Howmedica Corp.. Device class: 1.

Clearance details

Applicant: Howmedica Corp.
Product code: Code JDZ
Device class: Class 1
Regulation: 21 CFR 888.4210
Advisory panel: Orthopedic
Date received: 1985-08-07
Decision date: 1985-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rutherford, NJ, US

Download summary PDF View on FDA.gov ↗

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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

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K983404 — TYPE 3 FEMORAL COMPONENTS1998-12-22
K980925 — DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION1998-12-16
K980926 — DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION1998-12-16
K980626 — DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION1998-12-11

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.