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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 K203773
Device Name BRM TOOL Screws
Applicant
Brm Extremities Srl
Via Papa Giovanni Xxiii, 9
Civate,  IT 23862
Applicant Contact Andrea De Maglio
Correspondent
Mcra, LLC
1050 K. St. NW
Suite 1000
Washington,  DC  20001
Correspondent Contact Margeaux Rogers
Regulation Number888.3040
Classification Product Code
HWC  
Date Received12/23/2020
Decision Date 01/14/2022
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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