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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 K010738
Device Name CANNULATED PLUS SCREW SYSTEM
Applicant
Orthomatrix, Inc.
711 Chaney Cove
Collierville,  TN  38017
Applicant Contact BEN SHAPPLEY
Correspondent
Orthomatrix, Inc.
711 Chaney Cove
Collierville,  TN  38017
Correspondent Contact BEN SHAPPLEY
Regulation Number888.3040
Classification Product Code
HWC  
Date Received03/12/2001
Decision Date 08/01/2001
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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