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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 K210285
Device Name Adaptable Ortho Innovations Intramedullary Nail System
Applicant
Adaptable Ortho Innovations, LLC
65 Main St.
Potsdam,  NY  13676
Applicant Contact Steve Palin
Correspondent
Jalex Medical
27865 Clemens Rd.
Suite 3
Westlake,  OH  44145
Correspondent Contact Kyle Kovach
Regulation Number888.3020
Classification Product Code
HSB  
Date Received02/02/2021
Decision Date 03/18/2021
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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