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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Appliance, Fixation, Spinal Interlaminal
510(k) Number K133094
Device Name CERTEX OCT SPINAL IMPLANT SYSTEM
Applicant
X-SPINE SYSTEMS, INC
452 Alexandersville Rd
Miamisburg,  OH  45342
Applicant Contact DAVID KIRSCHMAN, M.D.
Correspondent
X-SPINE SYSTEMS, INC
452 Alexandersville Rd
Miamisburg,  OH  45342
Correspondent Contact DAVID KIRSCHMAN, M.D.
Regulation Number888.3050
Classification Product Code
KWP  
Date Received09/30/2013
Decision Date 12/11/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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