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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 K122959
Device Name HAMMER TOE IMPLANT
Applicant
TRILLIANT SURGICAL LTD
1001 OAKWOOD BLVD
ROUND ROCK,  TX  78681
Applicant Contact J D WEBB
Correspondent
TRILLIANT SURGICAL LTD
1001 OAKWOOD BLVD
ROUND ROCK,  TX  78681
Correspondent Contact J D WEBB
Regulation Number888.3040
Classification Product Code
HWC  
Date Received09/25/2012
Decision Date 11/07/2012
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
Recalls CDRH Recalls
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