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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Screw, Fixation, Bone
510(k) Number K930107
Device Name AME UNIVERSAL BONE SCREW
Applicant
American Medical Electronics, Inc.
250 E. Arapaho Rd.
Richardson,  TX  75081
Applicant Contact REBECCA S WHITE
Correspondent
American Medical Electronics, Inc.
250 E. Arapaho Rd.
Richardson,  TX  75081
Correspondent Contact REBECCA S WHITE
Regulation Number888.3040
Classification Product Code
HWC  
Date Received01/11/1993
Decision Date 02/22/1994
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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