FDA 510(k) Application Details - K142569

Device Classification Name	Prosthesis, Wrist, Hemi-, Ulnar   More FDA Info for this Device
510(K) Number	K142569
Device Name	Prosthesis, Wrist, Hemi-, Ulnar
Applicant	APTIS MEDICAL, LLC. 3602 GLENVIEW AVE. GLENVIEW, KY 40025 US Other 510(k) Applications for this Company
Contact	Bryann Babb Other 510(k) Applications for this Contact
Regulation Number	888.3810   More FDA Info for this Regulation Number
Classification Product Code	KXE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/12/2014
Decision Date	04/03/2015
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