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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 K091202
Device Name WEDGELOC 180X STANDARD SUTURE ANCHOR WITH OPTI FIBER SUTURES,MODEL 1000-01 TAB VARYING DIAMETERS,
Applicant
Medshape Solutions
1575 Northside Dr.
Suite 440
Atlanta,  GA  30318
Applicant Contact JACK GRIFFIS
Correspondent
Medshape Solutions
1575 Northside Dr.
Suite 440
Atlanta,  GA  30318
Correspondent Contact JACK GRIFFIS
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Codes
GAT   MBI  
Date Received04/24/2009
Decision Date 09/16/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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