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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spinal Pedicle Fixation
510(k) Number K033772
Device Name SHIRAZ-JAVA SPINAL FIXATION SYSTEM
Applicant
Spine Next America
104 Greenwood Creek Rd.
Queenstown,  MD  21658
Applicant Contact DIANE JOHNSON
Correspondent
Spine Next America
104 Greenwood Creek Rd.
Queenstown,  MD  21658
Correspondent Contact DIANE JOHNSON
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Code
MNH  
Date Received12/03/2003
Decision Date 01/27/2004
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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