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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 K001535
Device Name ZENITH PLATE SYSTEM, ANTERIOR SPINAL INSTRUMENTATION
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 Number888.3050
Classification Product Code
KWP  
Date Received05/17/2000
Decision Date 03/20/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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