FDA 510(k) Application Details - K130400

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K130400
Device Name	Screw, Fixation, Bone
Applicant	MERETE MEDICAL GMBH 102 ALT LANKWITZ BERLIN D-12247 DE Other 510(k) Applications for this Company
Contact	EMMANUEL ANAPLIOTIS Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	HWC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/19/2013
Decision Date	04/05/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review