THE MARGRON HIP REPLACEMENT SYSTEM— 510(k) K992815

Substantially Equivalent

Portland Orthopaedics Pty. , Ltd.

FDA 510(k) clearance K992815 for THE MARGRON HIP REPLACEMENT SYSTEM, Substantially Equivalent on 2000-02-07. Applicant: Portland Orthopaedics Pty. , Ltd..

Clearance details

Applicant: Portland Orthopaedics Pty. , Ltd.
Product code: Code MEH
Advisory panel: Orthopedic
Date received: 1999-08-20
Decision date: 2000-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kogarah, New South Wales, AU

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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.