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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name cement, bone, vertebroplasty
510(k) Number K220131
Device Name KYPHON VuE Bone Cement
Tecres S.p.A.
via Andrea Doria 6
Sommacampagna,  IT 37066
Applicant Contact Massio Grazioli
Brauer Device Consultants, LLC
7 Trail House Court
Rockville,  MD  20850
Correspondent Contact Christine Brauer
Regulation Number888.3027
Classification Product Code
Date Received01/18/2022
Decision Date 04/18/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No