FDA 510(k) Application Details - K121890

Device Classification Name	Fastener, Fixation, Biodegradable, Soft Tissue   More FDA Info for this Device
510(K) Number	K121890
Device Name	Fastener, Fixation, Biodegradable, Soft Tissue
Applicant	LINVATEC CORPORATION D/B/A CONMED LINVATEC 11311 Concept Boulevard LARGO, FL 33773 US Other 510(k) Applications for this Company
Contact	LORNA K LINVILLE Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	MAI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/28/2012
Decision Date	08/22/2012
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