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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name intervertebral fusion device with bone graft, lumbar
510(k) Number K210425
Device Name Catalyft PL Expandable Interbody System
Applicant
Medtronic Sofamor Danek, USA Inc.
1800 Pyramid Place
Memphis,  TN  38132
Applicant Contact Alex Underberg
Correspondent
Medtronic Sofamor Danek, USA Inc.
1800 Pyramid Place
Memphis,  TN  38132
Correspondent Contact Alex Underberg
Regulation Number888.3080
Classification Product Code
MAX  
Subsequent Product Code
OLO  
Date Received02/11/2021
Decision Date 05/24/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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