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FDA 510(k)

MUTARS Cemented Femoral Stems

K-Number: K200045 · 2020-10-16

ApplicantImplantcast GmbH
Decision Date2020-10-16
Product CodeMEH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MUTARS Cemented Femoral Stems is the device name listed in this FDA 510(k) record. The listed applicant is Implantcast GmbH. It received FDA 510(k) clearance on 2020-10-16 under 510(k) number K200045. 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 MUTARS Cemented Femoral Stems?

MUTARS Cemented Femoral Stems is a medical device that received FDA 510(k) clearance on 2020-10-16. The listed applicant is Implantcast GmbH. The 510(k) number is K200045.

When did MUTARS Cemented Femoral Stems receive FDA 510(k) clearance?

MUTARS Cemented Femoral Stems received FDA 510(k) clearance on 2020-10-16, under 510(k) number K200045.

Who is the listed applicant for MUTARS Cemented Femoral Stems?

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

What is the FDA product code for MUTARS Cemented Femoral Stems?

The FDA product code for MUTARS Cemented Femoral Stems is MEH.

Other records listing Implantcast GmbH 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.

K252451EPORE® XO cup systemK260037implantcast Packaging System UpdateK252401implaFit® short stemsK241944AGILON® XO Shoulder Replacement SystemK240391MUTARS® femoral stem cemented 160 mm and 200 mmK234044ACS® LD FB Knee System

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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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