FDA 510(k) Application Details - K053119

Device Classification Name	Prosthesis, Wrist, Hemi-, Ulnar   More FDA Info for this Device
510(K) Number	K053119
Device Name	Prosthesis, Wrist, Hemi-, Ulnar
Applicant	APTIS MEDICAL, LLC. 5 RIVER HILL RD. LOUISVILLE, KY 40207 US Other 510(k) Applications for this Company
Contact	BRYAN 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	11/07/2005
Decision Date	12/07/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review