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LINK TrabecuLink Femoral Cones

K201364 Class II Traditional
Decision Date
2020-07-17
Sponsor / Applicant
Waldemar Link GmbH & Co. KG

Technical Specification

510(k) Submission ID K201364
Product Code MBH
Medical Specialty / Panel Orthopedic
Regulation Citation 21 CFR 888.3565
Decision Date 2020-07-17
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

LINK TrabecuLink Femoral Cones received FDA 510(k) clearance under submission number K201364, sponsored by Waldemar Link GmbH & Co. KG. The device was reviewed via the Traditional premarket notification pathway and assigned to the Orthopedic review panel. The statutory decision date of record is 2020-07-17.

Classification & Regulation

This clearance is catalogued under FDA product code MBH and 21 CFR 888.3565, within the Orthopedic review panel as a Class II device.