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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 K161334
Device Name RASL Repair Kit
Applicant
Radicle Orthopaedics, Inc.
P.O. Box 7551
New York,  NY  10150
Applicant Contact EDWARD ROSENWASSER
Correspondent
Kapstone Medical, LLC
P.O. Box 969
Leicester,  NC  28748
Correspondent Contact JOHN KAPITAN
Regulation Number888.3040
Classification Product Code
HWC  
Date Received05/12/2016
Decision Date 02/09/2017
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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