FDA 510(k)

LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters

K-Number: K200607 · 2021-05-28

Decision Date2021-05-28

Product CodeLPH

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters 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 2021-05-28 under 510(k) number K200607. 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 - Dual Mobility Liners, and Shell/Insert Adapters?

LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters is a medical device that received FDA 510(k) clearance on 2021-05-28. The listed applicant is Waldemar Link GmbH & Co. KG. The 510(k) number is K200607.

When did LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters receive FDA 510(k) clearance?

LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters received FDA 510(k) clearance on 2021-05-28, under 510(k) number K200607.

Who is the listed applicant for LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters?

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 - Dual Mobility Liners, and Shell/Insert Adapters?

The FDA product code for LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters is LPH.

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.

NCT07207005Comparison of Wear Between Two Dual-mobility Acetabular Cups in Patients Undergoing Total Hip ArthroplastyRECRUITING NCT04090359Dual Mobility Acetabular Cups in Revision TJARECRUITING NCT06631638EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN))RECRUITING

Related Devices (Code: LPH)

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 Orthopaedics K243192iNSitu Lateralized Acetabular Liners, iNSitu Femoral Stems with Plasma Sprayed CPTi CoatingNextstep Arthopedix, LLC K251270Taperloc® Complete Hip StemBiomet, Inc.K252623G7® Revision Acetabular SystemZimmer, Inc.K251043Mpact 3D Metal Implants Extension – DMLS TechnologyMedacta International S.A.

Official Source

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