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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 K931381
Device Name AME UNIVERSAL FIXATION SYSTEM
Applicant
American Medical Electronics, Inc.
250 E. Arapaho Rd.
Richardson,  TX  75081
Applicant Contact KEITH JUNG
Correspondent
American Medical Electronics, Inc.
250 E. Arapaho Rd.
Richardson,  TX  75081
Correspondent Contact KEITH JUNG
Regulation Number888.3050
Classification Product Code
KWP  
Date Received03/18/1993
Decision Date 02/01/1995
Decision SUBSTANTIALLY EQUIVALENT FOR SOME INDICATIONS (SN)
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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