FDA 510(k) Application Details - K133691

Device Classification Name	Plate, Fixation, Bone   More FDA Info for this Device
510(K) Number	K133691
Device Name	Plate, Fixation, Bone
Applicant	OSTEOMED LP 3885 Arapaho Rd ADDISON, TX 75001 US Other 510(k) Applications for this Company
Contact	BLESSON ABRAHAM Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	HRS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/02/2013
Decision Date	02/24/2014
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