EXACTECH ALL POLY ACETABULAR CUP— 510(k) K934253

Name: FDA 510(k) clearance K934253
Creator: U.S. Food and Drug Administration
Published: 1994-04-29

Substantially Equivalent

Exactech, Inc.

FDA 510(k) clearance K934253 for EXACTECH ALL POLY ACETABULAR CUP, Substantially Equivalent on 1994-04-29. Applicant: Exactech, Inc.. Device class: 1.

Clearance details

Applicant: Exactech, Inc.
Product code: Code JDZ
Device class: Class 1
Regulation: 21 CFR 888.4210
Advisory panel: Orthopedic
Date received: 1993-08-31
Decision date: 1994-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gainesville, FL, US

Download summary PDF View on FDA.gov ↗

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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.