FDA 510(k) Application Details - K133520

Device Classification Name	Pin, Fixation, Smooth   More FDA Info for this Device
510(K) Number	K133520
Device Name	Pin, Fixation, Smooth
Applicant	BIOMEDICAL ENTERPRISES, INC 14785 OMICRON DR STE 205 SAN ANTONIO, TX 78245 US Other 510(k) Applications for this Company
Contact	JOE SOWARD 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	11/15/2013
Decision Date	01/09/2014
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