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FDA 510(k)

LINK® BiMobile(TM) Dual Mobility System

K-Number: K171273 · 2018-01-19

ApplicantWaldemar Link GmbH & Co. KG
Decision Date2018-01-19
Product CodeMEH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LINK® BiMobile(TM) Dual Mobility System is the device name listed in this FDA 510(k) record. The listed applicant is Waldemar Link GmbH & Co. KG. It received FDA 510(k) clearance on 2018-01-19 under 510(k) number K171273. 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 LINK® BiMobile(TM) Dual Mobility System?

LINK® BiMobile(TM) Dual Mobility System is a medical device that received FDA 510(k) clearance on 2018-01-19. The listed applicant is Waldemar Link GmbH & Co. KG. The 510(k) number is K171273.

When did LINK® BiMobile(TM) Dual Mobility System receive FDA 510(k) clearance?

LINK® BiMobile(TM) Dual Mobility System received FDA 510(k) clearance on 2018-01-19, under 510(k) number K171273.

Who is the listed applicant for LINK® BiMobile(TM) Dual Mobility System?

The FDA 510(k) record lists Waldemar Link GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LINK® BiMobile(TM) Dual Mobility System?

The FDA product code for LINK® BiMobile(TM) Dual Mobility System is MEH.

Other records listing Waldemar Link GmbH & Co. KG as applicant

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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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