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FDA 510(k)

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

K-Number: K200607 · 2021-05-28

ApplicantWaldemar Link GmbH & Co. KG
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 a medical device manufactured by Waldemar Link GmbH & Co. KG. It received FDA 510(k) clearance on 2021-05-28 under approval 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. It is manufactured by Waldemar Link GmbH & Co. KG. The 510(k) number is K200607.

When was LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters approved by the FDA?

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

What company makes 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 manufactured by Waldemar Link GmbH & Co. KG.

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.

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Other Devices by Waldemar Link GmbH & Co. KG

K152431LINK Endo-Model Knee System with PorEx (TiNbN) coating, Link Sled Knee System with PorEx (TiNbN) coating K161840LINK® SP-CL® Hip System PoroLink® (microporous) and HX® (CaP) coated & LINK® LCU® Hip System PoroLink® (microporous) and HX® (CaP) coated K171273LINK® BiMobile(TM) Dual Mobility System K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System) K190535BiMobile Dual Mobility System - E-Dur Inserts K191755SPAR-K Instruments (for use with Gemini SL Total Knee System)

View all 29 devices →

Related Devices (Code: LPH)

K162127Bencox M Stem Lateralized & Bencox Mirabo Cup SystemCorentec Co., Ltd. K161073Klassic HD Hip SystemTotal Joint Othopedics, Inc. K161569Trident® II Tritanium® Acetabular Shells and 6.5 mm Low Profile Hex ScrewsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics K161184iNSitu Total Hip SystemTheken Companies, LLC K151424The Progressive Orthopaedic Total Hip SystemThe Progressive Orthopaedic Company, LLC K161190G7 Dual Mobility System, Active Articulation SystemBiomet, 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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