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FDA 510(k)

Acetabular Bone Screws (for MobileLink Acetabular Cup System)

K-Number: K192559 · 2019-12-21

ApplicantWaldemar Link GmbH & Co. KG
Decision Date2019-12-21
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Acetabular Bone Screws (for MobileLink Acetabular Cup 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 2019-12-21 under 510(k) number K192559. 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 Acetabular Bone Screws (for MobileLink Acetabular Cup System)?

Acetabular Bone Screws (for MobileLink Acetabular Cup System) is a medical device that received FDA 510(k) clearance on 2019-12-21. The listed applicant is Waldemar Link GmbH & Co. KG. The 510(k) number is K192559.

When did Acetabular Bone Screws (for MobileLink Acetabular Cup System) receive FDA 510(k) clearance?

Acetabular Bone Screws (for MobileLink Acetabular Cup System) received FDA 510(k) clearance on 2019-12-21, under 510(k) number K192559.

Who is the listed applicant for Acetabular Bone Screws (for MobileLink Acetabular Cup 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 Acetabular Bone Screws (for MobileLink Acetabular Cup System)?

The FDA product code for Acetabular Bone Screws (for MobileLink Acetabular Cup System) 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.

NCT07515092Virtual Reality-Based Simulation Training for Antegrade Anterior Column Acetabular Screw Placement in Orthopedic ResidentsENROLLING_BY_INVITATION

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

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)K250375Allure Hip Stem and Intramedullary PlugsK243927MobileLink Acetabular Cup System - inhouse coatingsK241636MobileLink Acetabular Cup System - Line Extension (Multiple)K231445LINK Embrace Shoulder System - Reverse ConfigurationK222066LINK MobileLink Acetabular Cup System

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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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