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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 K061162
Device Name BAR PEDICLE SCREW SPINAL FIXATION SYSTEM, MODEL 2020
Applicant
Applied Spine Technologies, Inc.
300 George St., Suite 511
New Haven,  CT  06511
Applicant Contact MICHELE LUCEY
Correspondent
Applied Spine Technologies, Inc.
300 George St., Suite 511
New Haven,  CT  06511
Correspondent Contact MICHELE LUCEY
Regulation Number888.3070
Classification Product Code
MNH  
Subsequent Product Code
MNI  
Date Received04/26/2006
Decision Date 07/26/2006
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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