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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 K142534
Device Name HyProCure II
Applicant
Graham Medical Technologies, LLC Dba Gramedica
16137 Leone Dr.
Macomb,  MI  48042
Applicant Contact ANGELA RECCHIA
Correspondent
Secure BioMed Evaluations
7828 Hickory Flat Hwy., Suite 120
Woodstock,  GA  30188
Correspondent Contact LINDA BRADDON
Regulation Number888.3040
Classification Product Code
HWC  
Date Received09/09/2014
Decision Date 10/03/2014
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
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