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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Fixation, Bone
510(k) Number K935167
Device Name OGDEN ANCHOR (MODIFICATION)
Applicant
American Medical Electronics, Inc.
250 E. Arapaho Rd.
Richardson,  TX  75081
Applicant Contact BRUCE R HOROWITZ
Correspondent
American Medical Electronics, Inc.
250 E. Arapaho Rd.
Richardson,  TX  75081
Correspondent Contact BRUCE R HOROWITZ
Regulation Number888.3030
Classification Product Code
JDR  
Date Received10/27/1993
Decision Date 07/12/1994
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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