FDA 510(k) Application Details - K955848

Device Classification Name	Pin, Fixation, Threaded   More FDA Info for this Device
510(K) Number	K955848
Device Name	Pin, Fixation, Threaded
Applicant	ORTHOFIX, INC. 12300 TWINBROOK PKWY. SUITE 625 ROCKVILLE, MD 20852 US Other 510(k) Applications for this Company
Contact	ROBERT L SHERIDAN 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	12/27/1995
Decision Date	03/20/1996
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