ENCORE LINEAR POROUS COATED HIP WITH HA, ENCORE FOUNDATION POROUS HIP WITH HA, ENCORE REVELATION POROUS HIP WITH HA— 510(k) K993943

Name: FDA 510(k) clearance K993943
Creator: U.S. Food and Drug Administration
Published: 2000-02-04

Substantially Equivalent

Encore Orthopedics, Inc.

FDA 510(k) clearance K993943 for ENCORE LINEAR POROUS COATED HIP WITH HA, ENCORE FOUNDATION POROUS HIP WITH HA, ENCORE REVELATION POROUS HIP WITH HA, Substantially Equivalent on 2000-02-04. Applicant: Encore Orthopedics, Inc.. Device class: 2.

Clearance details

Applicant: Encore Orthopedics, Inc.
Product code: Code MEH
Device class: Class 2
Regulation: 21 CFR 888.3353
Advisory panel: Orthopedic
Date received: 1999-11-19
Decision date: 2000-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MEH

product code MEH

Injury: 2,021
Total: 2,021

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.