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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, Cervical
510(k) Number K142744
Device Name Mecta-C TiPEEK
Applicant
Medacta International
Strada Regina
Castel San Pietro,  CH 6874
Applicant Contact Adam Gross
Correspondent
Medacta USA
1556 W. Carroll Ave.
Chicago,  IL  60607
Correspondent Contact Michael G Loiterman
Regulation Number888.3080
Classification Product Code
ODP  
Date Received09/24/2014
Decision Date 05/07/2015
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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