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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 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 2020-03-18 under 510(k) 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. The listed applicant is Waldemar Link GmbH & Co. KG. The 510(k) number is K200113.

When did LINK TrabecuLink Tibial Cones receive FDA 510(k) clearance?

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

Who is the listed applicant for LINK TrabecuLink Tibial Cones?

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 LINK TrabecuLink Tibial Cones?

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

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

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Related Devices (Code: MBH)

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.

K251840Zimmer® Persona® Personalized Knee SystemZimmer, Inc.K253189Persona the Personalized Knee System (Persona Porous Plasma Spray PPS Femurs)Zimmer, Inc.K253328GMK 3D Metal Tibial Tray ExtensionMedacta International S.A.K253637Triathlon® Total Knee System - Triathlon® X3® Medial Stabilized Tibial Bearing InsertHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK253239Active-V Total Knee System; World Total Knee SystemSignature Orthopaedics Pty, Ltd.K253161Balanced Knee System TriMax Porous Femoral ComponentsOrtho Development Corp.

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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