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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 K864626
Device Name CANCELLOUS BONE SCREW
Applicant
Dow Corning Wright
P.O. Box 100
Arlington,  TN  38002
Applicant Contact BAILEY LIPSCOMB
Correspondent
Dow Corning Wright
P.O. Box 100
Arlington,  TN  38002
Correspondent Contact BAILEY LIPSCOMB
Regulation Number888.3040
Classification Product Code
HWC  
Date Received11/25/1986
Decision Date 12/15/1986
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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