ETEX HA HIP REPLACEMENT SYSTEM— 510(k) K935696

Name: FDA 510(k) clearance K935696
Creator: U.S. Food and Drug Administration
Published: 1994-07-22

Substantially Equivalent for Some Indications

Etex Corp.

FDA 510(k) clearance K935696 for ETEX HA HIP REPLACEMENT SYSTEM, Substantially Equivalent for Some Indications on 1994-07-22. Applicant: Etex Corp.. Device class: 2.

Clearance details

Applicant: Etex Corp.
Product code: Code MEH
Device class: Class 2
Regulation: 21 CFR 888.3353
Advisory panel: Orthopedic
Date received: 1993-11-30
Decision date: 1994-07-22
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Cambridge, MA, 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.