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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 K853869
Device Name TITANIUIM BONE SCREW
Applicant
George Tiemann & Co.
84 Newtown Plz.
Plainview,  NY  11803
Applicant Contact RICHARD MORIARTY
Correspondent
George Tiemann & Co.
84 Newtown Plz.
Plainview,  NY  11803
Correspondent Contact RICHARD MORIARTY
Regulation Number888.3040
Classification Product Code
HWC  
Date Received09/17/1985
Decision Date 12/09/1985
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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