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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 a medical device manufactured by Waldemar Link GmbH & Co. KG. It received FDA 510(k) clearance on 2018-01-19 under approval 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. It is manufactured by Waldemar Link GmbH & Co. KG. The 510(k) number is K171273.

When was LINK® BiMobile(TM) Dual Mobility System approved by the FDA?

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

What company makes LINK® BiMobile(TM) Dual Mobility System?

LINK® BiMobile(TM) Dual Mobility System is manufactured by Waldemar Link GmbH & Co. KG.

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.

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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 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) K182321MobileLink Acetabular Cup System

View all 29 devices →

Related Devices (Code: MEH)

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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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