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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 the device name listed in this FDA 510(k) record. The listed applicant is Waldemar Link GmbH & Co. KG. It received FDA 510(k) clearance on 2022-06-03 under 510(k) 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. The listed applicant is Waldemar Link GmbH & Co. KG. The 510(k) number is K211567.

When did BiMobile Instruments (for BiMobile Dual Mobility System) receive FDA 510(k) clearance?

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

Who is the listed applicant for BiMobile Instruments (for BiMobile Dual Mobility System)?

The FDA 510(k) record lists Waldemar Link GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

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.

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Related Devices (Code: LZO)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KGK260831Z1 Hip SystemZimmer, Inc.K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.K260037implantcast Packaging System UpdateImplantcast GmbHK252401implaFit® short stemsImplantcast GmbHK253171Libertas Taper Short (TS) Uncemented Femoral Stem (Libertas TS Stem)Maxx Orthopedics, 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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