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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 K993926
Device Name OMNIAXIAL CONNECTOR
Applicant
Ortho Tec, LLC
200 Gregory Ln. Suite C-100
Pleasant Hill,  CA  94523
Applicant Contact DAVID W SCHLERF
Correspondent
Ortho Tec, LLC
200 Gregory Ln. Suite C-100
Pleasant Hill,  CA  94523
Correspondent Contact DAVID W SCHLERF
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Codes
KWP   KWQ   MNI  
Date Received11/18/1999
Decision Date 12/17/1999
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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