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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 K873627
Device Name CTI STRAIGHT STEM
Applicant
ORTHOPEDIC SYSTEMS, INC.
1897 NATIONAL AVE.
HAYWARD,  CA  94545
Applicant Contact ROBERT R MOORE
Correspondent
ORTHOPEDIC SYSTEMS, INC.
1897 NATIONAL AVE.
HAYWARD,  CA  94545
Correspondent Contact ROBERT R MOORE
Regulation Number888.3360
Classification Product Code
JDG  
Date Received09/08/1987
Decision Date 12/30/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Type Traditional
Reviewed by Third Party No
Combination Product No
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