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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 K150309
Device Name Extremity Medical Calcaneal Osteotomy Device
Applicant
EXTREMITY MEDICAL, LLC
300 interpace pkwy ste 410
parsippany,  NJ  07054
Applicant Contact brian smekal
Correspondent
EXTREMITY MEDICAL, LLC
300 interpace pkwy ste 410
parsippany,  NJ  07054
Correspondent Contact brian smekal
Regulation Number888.3040
Classification Product Code
HWC  
Subsequent Product Code
HRS  
Date Received02/09/2015
Decision Date 03/04/2015
Decision substantially equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
summary summary
Type Special
Reviewed by Third Party No
Combination Product No
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