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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 K110633
Device Name LANCER PEDICLE SCREW SYSTEM
Applicant
SPINAL SOLUTIONS, LLC
1001 OAKWOOD BLVD
ROUND ROCK,  TX  78681
Applicant Contact J.D. WEBB
Correspondent
SPINAL SOLUTIONS, LLC
1001 OAKWOOD BLVD
ROUND ROCK,  TX  78681
Correspondent Contact J.D. WEBB
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Code
MNI  
Date Received03/04/2011
Decision Date 12/15/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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