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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spondylolisthesis Spinal Fixation
510(k) Number K110497
Device Name PASS LP SPINAL SYSTEM
Applicant
Medicrea International
1001 Oakwood Blvd.
Round Rock,  TX  78681
Applicant Contact J.D. WEBB
Correspondent
Medicrea International
1001 Oakwood Blvd.
Round Rock,  TX  78681
Correspondent Contact J.D. WEBB
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Codes
KWP   MNI  
Date Received02/22/2011
Decision Date 09/26/2011
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
Recalls CDRH Recalls
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