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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 K973005
Device Name THE CORIFIX LIGAMENT ANCHOR
Applicant
Corin USA
10500 University Center Dr.
Suite 190
Tampa,  FL  33612
Applicant Contact CRAIG CORRANCE
Correspondent
Corin USA
10500 University Center Dr.
Suite 190
Tampa,  FL  33612
Correspondent Contact CRAIG CORRANCE
Regulation Number888.3040
Classification Product Code
HWC  
Date Received08/13/1997
Decision Date 11/10/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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