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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 a medical device manufactured by Waldemar Link GmbH & Co. KG. It received FDA 510(k) clearance on 2019-12-21 under approval 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. It is manufactured by Waldemar Link GmbH & Co. KG. The 510(k) number is K192559.

When was Acetabular Bone Screws (for MobileLink Acetabular Cup System) approved by the FDA?

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

What company makes Acetabular Bone Screws (for MobileLink Acetabular Cup System)?

Acetabular Bone Screws (for MobileLink Acetabular Cup System) is manufactured by Waldemar Link GmbH & Co. KG.

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

NCT06631638 EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) RECRUITING NCT06409559 Rim Plate to Buttress Plate for Posterior Wall Acetabular Fractures With and Without Inter-fragmentary Screws RECRUITING NCT07515092 Virtual Reality-Based Simulation Training for Antegrade Anterior Column Acetabular Screw Placement in Orthopedic Residents ENROLLING_BY_INVITATION NCT05565131 Performance Measurement and Safety Evaluation of the PYTHEAS® ODYSSEE Angular Assistance System for Intra-pedicular Screw Placement in Adult Spine Surgery COMPLETED

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 K190535BiMobile Dual Mobility System - E-Dur Inserts K191755SPAR-K Instruments (for use with Gemini SL Total Knee System) K182321MobileLink Acetabular Cup System

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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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