FDA 510(k) Application Details - K960023

Device Classification Name	Pin, Fixation, Threaded   More FDA Info for this Device
510(K) Number	K960023
Device Name	Pin, Fixation, Threaded
Applicant	PROMEX, INC. 1125 BROOKSIDE AVE. SUITE G500 INDIANAPOLIS, IN 46202 US Other 510(k) Applications for this Company
Contact	JOSEPH L MARK Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	JDW Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/02/1996
Decision Date	03/18/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review