FDA 510(k) Application Details - K211385

Device Classification Name	Prosthesis, Finger, Constrained, Polymer   More FDA Info for this Device
510(K) Number	K211385
Device Name	Prosthesis, Finger, Constrained, Polymer
Applicant	Keri Medical SA Route des Acacias, 45a Geneva CH-1227 CH Other 510(k) Applications for this Company
Contact	Bernard Prandi 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	05/04/2021
Decision Date	07/27/2022
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