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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Fixation, Spinal Interlaminal
510(k) Number K890185
Device Name C-S IMPACTOR
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 Number888.3050
Classification Product Code
LYP  
Date Received01/18/1989
Decision Date 04/06/1989
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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