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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 K090033
Device Name MODIFICATION TO: PSS SYSTEM
Applicant
Spinal USA
2050 Executive Dr..
Pear,  MS  39208
Applicant Contact JEFFREY JOHNSON
Correspondent
Spinal USA
2050 Executive Dr..
Pear,  MS  39208
Correspondent Contact JEFFREY JOHNSON
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Code
MNH  
Date Received01/06/2009
Decision Date 05/06/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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