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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 K133192
Device Name MECTALIF TIPEEK
Applicant
Medacta International
4725 Calle Quetzal Unit B
Camarillo,  CA  93012
Applicant Contact ADAM GROSS
Correspondent
Medacta International
4725 Calle Quetzal Unit B
Camarillo,  CA  93012
Correspondent Contact ADAM GROSS
Regulation Number888.3080
Classification Product Code
MAX  
Date Received10/17/2013
Decision Date 01/30/2014
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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