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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 K210146
Device Name Cannulated Compression Device System
Applicant
Orthopedic Designs North America, Inc.
5912 Breckridge Pkwy.
Suite F
Tampa,  FL  33610
Applicant Contact Robin Wilson
Correspondent
Orthopedic Designs North America, Inc.
5912 Breckridge Pkwy.
Suite F
Tampa,  FL  33610
Correspondent Contact Robin Wilson
Regulation Number888.3040
Classification Product Code
HWC  
Date Received01/21/2021
Decision Date 04/13/2022
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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