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FDA 510(k)

LINK MobileLink Acetabular Cup System

K-Number: K222066 · 2023-04-14

ApplicantWaldemar Link GmbH & Co. KG
Decision Date2023-04-14
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LINK MobileLink Acetabular Cup 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 2023-04-14 under 510(k) number K222066. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LINK MobileLink Acetabular Cup System?

LINK MobileLink Acetabular Cup System is a medical device that received FDA 510(k) clearance on 2023-04-14. The listed applicant is Waldemar Link GmbH & Co. KG. The 510(k) number is K222066.

When did LINK MobileLink Acetabular Cup System receive FDA 510(k) clearance?

LINK MobileLink Acetabular Cup System received FDA 510(k) clearance on 2023-04-14, under 510(k) number K222066.

Who is the listed applicant for LINK MobileLink Acetabular Cup 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 MobileLink Acetabular Cup System?

The FDA product code for LINK MobileLink Acetabular Cup System is LPH.

Other records listing Waldemar Link GmbH & Co. KG 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.

K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)K250375Allure Hip Stem and Intramedullary PlugsK243927MobileLink Acetabular Cup System - inhouse coatingsK241636MobileLink Acetabular Cup System - Line Extension (Multiple)K231445LINK Embrace Shoulder System - Reverse ConfigurationK230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface

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Related Devices (Code: LPH)

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.

K254043TRIVANCE™ Hip StemGlobus Medical, Inc.K261624Omnifit® 20° Series I Insert;Omnifit® Crossfire® 10° Series II Insert; Constrained Acetabular Insert; Trident® Crossfire® 0° Polyethylene Insert; Trident ® Crossfire ® 10° Polyethylene Insert;System 12 Crossfire® 10° Insert; Trident® 0° Constrained Acetabular Insert; Trident® Constrained Acetabular Liner;Trident® All Poly Constrained Acetabular Insert; Crossfire® Eccentric Insert 10°; Artisan® Bone Plug;UHR® Universal Head Bipolar ComponentHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLCK251270Taperloc® Complete Hip StemBiomet, Inc.K252623G7® Revision Acetabular SystemZimmer, Inc.K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.

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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