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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 K022768
Device Name AMT POLYAXIAL PEDICLE SCREW
Applicant
Micron Precision Engineering, Inc.
939 Evening Shade Dr.
San Pedro,  CA  90731
Applicant Contact FRANK E BAILEY
Correspondent
Micron Precision Engineering, Inc.
939 Evening Shade Dr.
San Pedro,  CA  90731
Correspondent Contact FRANK E BAILEY
Regulation Number888.3070
Classification Product Code
MNI  
Subsequent Product Code
MNH  
Date Received08/21/2002
Decision Date 11/13/2002
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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