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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 K112862
Device Name MECTA-C
Original Applicant
MEDACTA INTERNATIONAL
4725 calle quetzal, unit b
camarillo,  CA  93012
Original Contact adam gross
Regulation Number888.3080
Classification Product Code
ODP  
Date Received09/30/2011
Decision Date 12/19/2011
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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