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FDA 510(k)

MobileLink Acetabular Cup System - Line Extension (Multiple)

K-Number: K241636 · 2024-11-08

ApplicantWaldemar Link GmbH & Co. KG
Decision Date2024-11-08
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MobileLink Acetabular Cup System - Line Extension (Multiple) is a medical device manufactured by Waldemar Link GmbH & Co. KG. It received FDA 510(k) clearance on 2024-11-08 under approval number K241636. 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 MobileLink Acetabular Cup System - Line Extension (Multiple)?

MobileLink Acetabular Cup System - Line Extension (Multiple) is a medical device that received FDA 510(k) clearance on 2024-11-08. It is manufactured by Waldemar Link GmbH & Co. KG. The 510(k) number is K241636.

When was MobileLink Acetabular Cup System - Line Extension (Multiple) approved by the FDA?

MobileLink Acetabular Cup System - Line Extension (Multiple) received FDA 510(k) clearance on 2024-11-08, under approval number K241636.

What company makes MobileLink Acetabular Cup System - Line Extension (Multiple)?

MobileLink Acetabular Cup System - Line Extension (Multiple) is manufactured by Waldemar Link GmbH & Co. KG.

What is the FDA product code for MobileLink Acetabular Cup System - Line Extension (Multiple)?

The FDA product code for MobileLink Acetabular Cup System - Line Extension (Multiple) is LPH.

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Related PubMed Literature

PMID: 41336744 From laboratory to pre-market prototyping: lessons learned from a noninvasive blood glucose level measurement device. Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference (2025)

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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