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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 K002059
Device Name AMT SPINAL SYSTEM
Applicant
Micron Precision Engineering, Inc.
939 Evening Shade Dr.
San Pedro,  CA  90731
Applicant Contact FRANK E BAILY
Correspondent
Micron Precision Engineering, Inc.
939 Evening Shade Dr.
San Pedro,  CA  90731
Correspondent Contact FRANK E BAILY
Regulation Number888.3050
Classification Product Code
KWP  
Subsequent Product Code
MNH  
Date Received07/06/2000
Decision Date 11/13/2000
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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