FDA 510(k) Application Details - K123885

Device Classification Name	More FDA Info for this Device
510(K) Number	K123885
Device Name	OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR
Applicant	OSTEOMED LP 3885 Arapaho Rd ADDISON, TX 75001 US Other 510(k) Applications for this Company
Contact	PIEDAD PENA Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PBJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/18/2012
Decision Date	06/03/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	NE - Neurology
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review