FDA 510(k) Application Details - K181639

Device Classification Name	Rod, Fixation, Intramedullary And Accessories   More FDA Info for this Device
510(K) Number	K181639
Device Name	Rod, Fixation, Intramedullary And Accessories
Applicant	Integra Lifesciences Corporation 11101 Metric Blvd. Austin, TX 78758 US Other 510(k) Applications for this Company
Contact	Blesson Abraham Other 510(k) Applications for this Contact
Regulation Number	888.3020   More FDA Info for this Regulation Number
Classification Product Code	HSB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/21/2018
Decision Date	11/02/2018
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review