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FDA 510(k)

ETEX HA HIP REPLACEMENT SYSTEM

K-Number: K935696 · 1994-07-22

ApplicantEtex Corp.
Decision Date1994-07-22
Product CodeMEH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

ETEX HA HIP REPLACEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Etex Corp.. It received FDA 510(k) clearance on 1994-07-22 under 510(k) number K935696. The device is classified under product code MEH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the ETEX HA HIP REPLACEMENT SYSTEM?

ETEX HA HIP REPLACEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 1994-07-22. The listed applicant is Etex Corp.. The 510(k) number is K935696.

When did ETEX HA HIP REPLACEMENT SYSTEM receive FDA 510(k) clearance?

ETEX HA HIP REPLACEMENT SYSTEM received FDA 510(k) clearance on 1994-07-22, under 510(k) number K935696.

Who is the listed applicant for ETEX HA HIP REPLACEMENT SYSTEM?

The FDA 510(k) record lists Etex Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ETEX HA HIP REPLACEMENT SYSTEM?

The FDA product code for ETEX HA HIP REPLACEMENT SYSTEM is MEH.

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Other records listing Etex Corp. 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.

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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

View on FDA Database →

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

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