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FDA 510(k)

BiMobile Instruments (for BiMobile Dual Mobility System)

K-Number: K211567 · 2022-06-03

ApplicantWaldemar Link GmbH & Co. KG
Decision Date2022-06-03
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

BiMobile Instruments (for BiMobile Dual Mobility System) is a medical device manufactured by Waldemar Link GmbH & Co. KG. It received FDA 510(k) clearance on 2022-06-03 under approval number K211567. 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 Instruments (for BiMobile Dual Mobility System)?

BiMobile Instruments (for BiMobile Dual Mobility System) is a medical device that received FDA 510(k) clearance on 2022-06-03. It is manufactured by Waldemar Link GmbH & Co. KG. The 510(k) number is K211567.

When was BiMobile Instruments (for BiMobile Dual Mobility System) approved by the FDA?

BiMobile Instruments (for BiMobile Dual Mobility System) received FDA 510(k) clearance on 2022-06-03, under approval number K211567.

What company makes BiMobile Instruments (for BiMobile Dual Mobility System)?

BiMobile Instruments (for BiMobile Dual Mobility System) is manufactured by Waldemar Link GmbH & Co. KG.

What is the FDA product code for BiMobile Instruments (for BiMobile Dual Mobility System)?

The FDA product code for BiMobile Instruments (for BiMobile Dual Mobility System) is LZO.

Related Clinical Trials

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Related PubMed Literature

PMID: 41619565 Integration of materiovigilance in Unani medicine: A step towards patient safety. Journal of Ayurveda and integrative medicine (2026)

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)

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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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