FDA 510(k) Application Details - K101616

Device Classification Name	Fastener, Fixation, Nondegradable, Soft Tissue   More FDA Info for this Device
510(K) Number	K101616
Device Name	Fastener, Fixation, Nondegradable, Soft Tissue
Applicant	TAG MEDICAL CORP. 291 Hillside Avenue Somerset, MA 02726 US Other 510(k) Applications for this Company
Contact	GEORGE J HATTUB Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	MBI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/09/2010
Decision Date	01/06/2011
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