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FDA 510(k)

ESOP S/C FEMORAL STEM

K-Number: K964878 · 1998-03-05

ApplicantFournitures Hospitalieres
Decision Date1998-03-05
Product CodeMEH
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

ESOP S/C FEMORAL STEM is the device name listed in this FDA 510(k) record. The listed applicant is Fournitures Hospitalieres. It received FDA 510(k) clearance on 1998-03-05 under 510(k) number K964878. 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 ESOP S/C FEMORAL STEM?

ESOP S/C FEMORAL STEM is a medical device that received FDA 510(k) clearance on 1998-03-05. The listed applicant is Fournitures Hospitalieres. The 510(k) number is K964878.

When did ESOP S/C FEMORAL STEM receive FDA 510(k) clearance?

ESOP S/C FEMORAL STEM received FDA 510(k) clearance on 1998-03-05, under 510(k) number K964878.

Who is the listed applicant for ESOP S/C FEMORAL STEM?

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

What is the FDA product code for ESOP S/C FEMORAL STEM?

The FDA product code for ESOP S/C FEMORAL STEM is MEH.

Related Clinical Trials

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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Other records listing Fournitures Hospitalieres 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.

K021109ESOP CO-CR FEMORAL HEADSK021108ESOP HA FEMORAL STEMK961388ATLAS III ACETABULAR CUP

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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