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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 K042079
Device Name OSS/(SCARF)- AND OSW-SCREW
Applicant
O.M.T. Oberflachen-Und Materialtechnologie GmbH
1327 7th Ave.
Huntington,  WV  25701
Applicant Contact H. DARREL DARBY II
Correspondent
O.M.T. Oberflachen-Und Materialtechnologie GmbH
1327 7th Ave.
Huntington,  WV  25701
Correspondent Contact H. DARREL DARBY II
Regulation Number888.3040
Classification Product Code
HWC  
Date Received08/02/2004
Decision Date 12/20/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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