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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
Recalls CDRH Recalls
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