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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Orthosis, Spinal Pedicle Fixation
510(k) Number K992147
Device Name TRIPLE-FIX SPINAL FIXATION SYSTEM
Applicant
Advanced Spine Technology, Inc.
3645 Grand Ave., Suite 304
Oakland,  CA  94610
Applicant Contact GORDON TAO
Correspondent
Advanced Spine Technology, Inc.
3645 Grand Ave., Suite 304
Oakland,  CA  94610
Correspondent Contact GORDON TAO
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Codes
KWP   MNH  
Date Received06/24/1999
Decision Date 02/28/2000
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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