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FDA 510(k)

LINK TrabecuLink Tibial Cones

K-Number: K200113 · 2020-03-18

ApplicantWaldemar Link GmbH & Co. KG
Decision Date2020-03-18
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LINK TrabecuLink Tibial Cones is a medical device manufactured by Waldemar Link GmbH & Co. KG. It received FDA 510(k) clearance on 2020-03-18 under approval number K200113. The device is classified under product code MBH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LINK TrabecuLink Tibial Cones?

LINK TrabecuLink Tibial Cones is a medical device that received FDA 510(k) clearance on 2020-03-18. It is manufactured by Waldemar Link GmbH & Co. KG. The 510(k) number is K200113.

When was LINK TrabecuLink Tibial Cones approved by the FDA?

LINK TrabecuLink Tibial Cones received FDA 510(k) clearance on 2020-03-18, under approval number K200113.

What company makes LINK TrabecuLink Tibial Cones?

LINK TrabecuLink Tibial Cones is manufactured by Waldemar Link GmbH & Co. KG.

What is the FDA product code for LINK TrabecuLink Tibial Cones?

The FDA product code for LINK TrabecuLink Tibial Cones is MBH.

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 K192559Acetabular Bone Screws (for MobileLink Acetabular Cup System) K190535BiMobile Dual Mobility System - E-Dur Inserts K191755SPAR-K Instruments (for use with Gemini SL Total Knee System)

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Related Devices (Code: MBH)

K162256Klassic Femur, Porous, Klassic Tibial Baseplate, PorousTotal Joint Orthopedics, Inc. K153657Vanguard XP Knee SystemBiomet, Inc. K153776Optetrak One Logic Femoral ComponentsExactech, Inc. K153586Arthrex iBalance TKA SystemArthrex, Inc. K172634Triathlon® X3® UHMWPE Tibial Inserts and Patellar ComponentsHowmedica Osteonics Corp. A.K.A. Stryker Orthopaedics K171365Arthrex Knee SystemsArthrex, 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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