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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 K072282
Device Name CAPLESS LI PEDICLE SCREW SYSTEM
Applicant
X-Spine Systems, Inc.
452 Alexandersville Rd.
Miamisburg,  OH  45342
Applicant Contact DAVID KIRSCHMAN
Correspondent
X-Spine Systems, Inc.
452 Alexandersville Rd.
Miamisburg,  OH  45342
Correspondent Contact DAVID KIRSCHMAN
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Code
MNI  
Date Received08/16/2007
Decision Date 09/14/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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