FDA 510(k) Application Details - K150376

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K150376
Device Name	Screw, Fixation, Bone
Applicant	Sonoma Orthopedics Products, Inc 3589 Westwind Blvd Santa Rosa, CA 95403 US Other 510(k) Applications for this Company
Contact	Rick Epstein 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	02/13/2015
Decision Date	06/12/2015
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