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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 K993503
Device Name HAIDER-UCR SPINAL SYSTEM
Applicant
International Advanced Medical Enterprises, Inc.
200 Gregory Ln. Suite C-100
Pleasant Hill,  CA  94523
Applicant Contact DAVID W SCHLERF
Correspondent
International Advanced Medical Enterprises, Inc.
200 Gregory Ln. Suite C-100
Pleasant Hill,  CA  94523
Correspondent Contact DAVID W SCHLERF
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Code
MNI  
Date Received10/15/1999
Decision Date 04/14/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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