FDA 510(k) Application Details - K133523

Device Classification Name	Staple, Fixation, Bone   More FDA Info for this Device
510(K) Number	K133523
Device Name	Staple, Fixation, Bone
Applicant	INSTRATEK, INC. 15200 Middlebrook Dr Ste G Houston, TX 77058 US Other 510(k) Applications for this Company
Contact	Jeff Seavey Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	JDR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/15/2013
Decision Date	02/06/2014
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