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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 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 2019-08-06 under 510(k) 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. The listed applicant is Waldemar Link GmbH & Co. KG. The 510(k) number is K190535.

When did BiMobile Dual Mobility System - E-Dur Inserts receive FDA 510(k) clearance?

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

Who is the listed applicant for BiMobile Dual Mobility System - E-Dur Inserts?

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 Dual Mobility System - E-Dur Inserts?

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

Related Clinical Trials

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.

NCT07207005Comparison of Wear Between Two Dual-mobility Acetabular Cups in Patients Undergoing Total Hip ArthroplastyRECRUITING

Other records listing Waldemar Link GmbH & Co. KG as applicant

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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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