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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Hip, Femoral Component, Cemented, Metal
510(k) Number K780497
Device Name SPHERISTEM TOTAL HIP PROSTHESIS
Applicant
American Ortomed Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
American Ortomed Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number888.3360
Classification Product Code
JDG  
Date Received03/28/1978
Decision Date 06/14/1978
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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