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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Staple, Fixation, Bone
510(k) Number K173775
Device Name Clench Compression Staple
Applicant
F & A Foundation, LLC D.B.A. Reign Medical
6303 E 102nd St. Suite 200
Tulsa,  OK  74137
Applicant Contact Daniel Lanois
Correspondent
Surgop Support, LLC
3270 Walton Riverwood Ln. SE #4025
Atlanta,  GA  30339
Correspondent Contact Daniel Lanois
Regulation Number888.3030
Classification Product Code
JDR  
Date Received12/12/2017
Decision Date 04/06/2018
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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