FDA 510(k) Application Details - K190543

Device Classification Name	Prosthesis, Toe, Hemi-, Phalangeal   More FDA Info for this Device
510(K) Number	K190543
Device Name	Prosthesis, Toe, Hemi-, Phalangeal
Applicant	Vilex in Tennessee, Inc. 111 Moffitt Street McMinnville, TN 37110 US Other 510(k) Applications for this Company
Contact	Sylvia Southard Other 510(k) Applications for this Contact
Regulation Number	888.3730   More FDA Info for this Regulation Number
Classification Product Code	KWD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/04/2019
Decision Date	05/31/2019
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