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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 K111265
Device Name METASURG SUBTALAR IMPLANT
Original Applicant
METASURG
16350 park ten pl., suite 101
houston,  TX  77084
Original Contact joshua scott
Regulation Number888.3040
Classification Product Code
HWC  
Date Received05/04/2011
Decision Date 08/09/2011
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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