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FDA 510(k)

LINK TrabecuLink Femoral Cones

K-Number: K201364 · 2020-07-17

ApplicantWaldemar Link GmbH & Co. KG
Decision Date2020-07-17
Product CodeMBH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LINK TrabecuLink Femoral 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 2020-07-17 under 510(k) number K201364. 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 Femoral Cones?

LINK TrabecuLink Femoral Cones is a medical device that received FDA 510(k) clearance on 2020-07-17. The listed applicant is Waldemar Link GmbH & Co. KG. The 510(k) number is K201364.

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

LINK TrabecuLink Femoral Cones received FDA 510(k) clearance on 2020-07-17, under 510(k) number K201364.

Who is the listed applicant for LINK TrabecuLink Femoral 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 Femoral Cones?

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

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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.

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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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