Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MobileLink Acetabular Cup System – 40mm ID Inserts (various)

K-Number: K261009 · 2026-07-06

ApplicantWaldemar Link GmbH & Co. KG
Decision Date2026-07-06
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MobileLink Acetabular Cup System – 40mm ID Inserts (various) 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 2026-07-06 under 510(k) number K261009. 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 MobileLink Acetabular Cup System – 40mm ID Inserts (various)?

MobileLink Acetabular Cup System – 40mm ID Inserts (various) is a medical device that received FDA 510(k) clearance on 2026-07-06. The listed applicant is Waldemar Link GmbH & Co. KG. The 510(k) number is K261009.

When did MobileLink Acetabular Cup System – 40mm ID Inserts (various) receive FDA 510(k) clearance?

MobileLink Acetabular Cup System – 40mm ID Inserts (various) received FDA 510(k) clearance on 2026-07-06, under 510(k) number K261009.

Who is the listed applicant for MobileLink Acetabular Cup System – 40mm ID Inserts (various)?

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 MobileLink Acetabular Cup System – 40mm ID Inserts (various)?

The FDA product code for MobileLink Acetabular Cup System – 40mm ID Inserts (various) is LZO.

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.

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 SystemK230471LinkSymphoKnee – Fixed Bearing Ultracongruent (FB UC) Articulating Surface

View all 30 devices →

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.

K260831Z1 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.K250450Coated hip implantsMedacta International S.A.

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.

↑