FDA 510(k) Application Details - K140414

Device Classification Name	Orthopedic Manual Surgical Instrument   More FDA Info for this Device
510(K) Number	K140414
Device Name	Orthopedic Manual Surgical Instrument
Applicant	ORTHOVITA, INC. 77 Great Valley Parkway Malvern, PA 19355 US Other 510(k) Applications for this Company
Contact	John Urtz Other 510(k) Applications for this Contact
Regulation Number	888.4540   More FDA Info for this Regulation Number
Classification Product Code	LXH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/18/2014
Decision Date	04/01/2014
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