FDA 510(k) Application Details - K031981

Device Classification Name	Fastener, Fixation, Biodegradable, Soft Tissue   More FDA Info for this Device
510(K) Number	K031981
Device Name	Fastener, Fixation, Biodegradable, Soft Tissue
Applicant	LINVATEC BIOMATERIALS, LTD. 1311 CONCEPT BLVD LARGO, FL 33773 US Other 510(k) Applications for this Company
Contact	LAURA KREJCI 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	06/26/2003
Decision Date	07/25/2003
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