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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 K161254
Device Name Renovo Life Small Bone IM Nail System
Applicant
Renovo Life, LLC
1104 Spruce St.
Belmont,  NC  28012
Applicant Contact Harold Crowder
Correspondent
Orgenix, LLC
111 Hill Rd.
Douglassville,  PA  19518
Correspondent Contact Donald W. Guthner
Regulation Number888.3020
Classification Product Code
HSB  
Date Received05/03/2016
Decision Date 11/07/2016
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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