FDA 510(k) Application Details - K101375

Device Classification Name	System, External Fixator (With Metallic Invasive Components)   More FDA Info for this Device
510(K) Number	K101375
Device Name	System, External Fixator (With Metallic Invasive Components)
Applicant	TRIMED, INC. 28337 MAITLAND LANE SAUGUS, CA 91350 US Other 510(k) Applications for this Company
Contact	KELLI ANDERSON Other 510(k) Applications for this Contact
Regulation Number	888.3040   More FDA Info for this Regulation Number
Classification Product Code	NDK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/17/2010
Decision Date	09/15/2010
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