FDA 510(k) Application Details - K220142

Device Classification Name	Prosthesis, Finger, Constrained, Polymer   More FDA Info for this Device
510(K) Number	K220142
Device Name	Prosthesis, Finger, Constrained, Polymer
Applicant	BRM Extremities Srl Via Papa Giovanni XXIII, 9 Civate 23862 IT Other 510(k) Applications for this Company
Contact	Andrea De Maglio Other 510(k) Applications for this Contact
Regulation Number	888.3230   More FDA Info for this Regulation Number
Classification Product Code	KYJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/18/2022
Decision Date	04/04/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review