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FDA 510(k)

MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEM

K-Number: K032641 · 2004-01-20

ApplicantPortland Orthopaedics Pty. , Ltd.
Decision Date2004-01-20
Product CodeMEH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Portland Orthopaedics Pty. , Ltd.. It received FDA 510(k) clearance on 2004-01-20 under 510(k) number K032641. The device is classified under product code MEH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEM?

MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2004-01-20. The listed applicant is Portland Orthopaedics Pty. , Ltd.. The 510(k) number is K032641.

When did MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEM receive FDA 510(k) clearance?

MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEM received FDA 510(k) clearance on 2004-01-20, under 510(k) number K032641.

Who is the listed applicant for MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEM?

The FDA 510(k) record lists Portland Orthopaedics Pty. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEM?

The FDA product code for MODIFICATION TO: THE MARGRON HIP REPLACEMENT SYSTEM is MEH.

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Other records listing Portland Orthopaedics Pty. , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K061564PORTLAND CERAMIC (BIOLOX-FORTE) FEMORAL HEADK053417M-COR HIP REPLACEMENT SYSTEMK051844EQUATOR PLUS ACETABULAR CUP SYSTEMK992815THE MARGRON HIP REPLACEMENT SYSTEM

Related Devices (Code: MEH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261576Icona Hip StemCorin, Ltd.K250375Allure Hip Stem and Intramedullary PlugsWaldemar Link GmbH & Co. KGK251166Mfinity Femoral SystemMedacta International S.A.K251052Trivicta® Hip StemOrtho Development Corp.K242315Resolve Modular Revision Hip StemUnited Orthopedic CorporationK243839Alteon® HA Femoral StemsExactech, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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