FDA 510(k) Application Details - K133950

Device Classification Name	Pin, Fixation, Smooth   More FDA Info for this Device
510(K) Number	K133950
Device Name	Pin, Fixation, Smooth
Applicant	BIORETEC LTD. HERMIANKATU 22, MODULIGTH BUILDING TAMPERE FI-33720 FI Other 510(k) Applications for this Company
Contact	MINNA RASANEN Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	HTY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/23/2013
Decision Date	01/22/2014
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