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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Rod, Fixation, Intramedullary And Accessories
510(k) Number K152757
Device Name SIGN Hip Construct (SHC)
Applicant
Sign Fracture Care International
451 Hills St., Suite B
Richland,  WA  99354
Applicant Contact Rob Teeter
Correspondent
Sign Fracture Care International
451 Hills St., Suite B
Richland,  WA  99354
Correspondent Contact Rob Teeter
Regulation Number888.3020
Classification Product Code
HSB  
Subsequent Product Codes
HRS   KTT  
Date Received09/24/2015
Decision Date 11/13/2015
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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