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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prosthesis, Finger, Constrained, Polymer
510(k) Number K220142
Device Name BRM Digitalis Spacer
Applicant
Brm Extremities Srl
Via Papa Giovanni Xxiii, 9
Civate,  IT 23862
Applicant Contact Andrea De Maglio
Correspondent
MCRA, LLC
803 7th St. NW
Washington,  DC  20001
Correspondent Contact Margeaux Rogers
Regulation Number888.3230
Classification Product Code
KYJ  
Date Received01/18/2022
Decision Date 04/04/2023
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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