FDA 510(k) Application Details - K003659

Device Classification Name	Pin, Fixation, Smooth   More FDA Info for this Device
510(K) Number	K003659
Device Name	Pin, Fixation, Smooth
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	888.3040   More FDA Info for this Regulation Number
Classification Product Code	HTY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/28/2000
Decision Date	02/20/2001
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