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FDA 510(k)

BiMobile Dual Mobility System - E-Dur Inserts

K-Number: K190535 · 2019-08-06

ApplicantWaldemar Link GmbH & Co. KG
Decision Date2019-08-06
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BiMobile Dual Mobility System - E-Dur Inserts is a medical device manufactured by Waldemar Link GmbH & Co. KG. It received FDA 510(k) clearance on 2019-08-06 under approval number K190535. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BiMobile Dual Mobility System - E-Dur Inserts?

BiMobile Dual Mobility System - E-Dur Inserts is a medical device that received FDA 510(k) clearance on 2019-08-06. It is manufactured by Waldemar Link GmbH & Co. KG. The 510(k) number is K190535.

When was BiMobile Dual Mobility System - E-Dur Inserts approved by the FDA?

BiMobile Dual Mobility System - E-Dur Inserts received FDA 510(k) clearance on 2019-08-06, under approval number K190535.

What company makes BiMobile Dual Mobility System - E-Dur Inserts?

BiMobile Dual Mobility System - E-Dur Inserts is manufactured by Waldemar Link GmbH & Co. KG.

What is the FDA product code for BiMobile Dual Mobility System - E-Dur Inserts?

The FDA product code for BiMobile Dual Mobility System - E-Dur Inserts is LZO.

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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) K191755SPAR-K Instruments (for use with Gemini SL Total Knee System) K182321MobileLink Acetabular Cup System

View all 29 devices →

Related Devices (Code: LZO)

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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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