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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Interlaminal
510(k) Number K121115
Device Name M.U.S.T PEDICLE SCREW SYSTEM
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 Number888.3050
Classification Product Code
KWP  
Subsequent Product Codes
KWQ   MNH   MNI   NKB  
Date Received04/12/2012
Decision Date 07/18/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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