FDA 510(k) Application Details - K152662

Device Classification Name	Pin, Fixation, Smooth   More FDA Info for this Device
510(K) Number	K152662
Device Name	Pin, Fixation, Smooth
Applicant	Spinal Resources Inc 274 E Eau Gallie Blvd Unit 303 Indian Harbour Beach, FL 32937 US Other 510(k) Applications for this Company
Contact	Bernard Bedor Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	HTY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/17/2015
Decision Date	03/09/2016
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