FDA 510(k) Application Details - K012334

Device Classification Name	Fastener, Fixation, Biodegradable, Soft Tissue   More FDA Info for this Device
510(K) Number	K012334
Device Name	Fastener, Fixation, Biodegradable, Soft Tissue
Applicant	BIONX IMPLANTS, INC. HERMIANKATU 6-8 L TAMPERE FIN-33720 FI Other 510(k) Applications for this Company
Contact	TUIJA ANNALA 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	07/24/2001
Decision Date	09/19/2001
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