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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 K792022
Device Name HERBERT BONE SCREW
Applicant
ZIMMER, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
ZIMMER, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number888.3040
Classification Product Code
HWC  
Date Received10/09/1979
Decision Date 10/26/1979
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
Recalls CDRH Recalls
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