FDA 510(k) Application Details - K012000

Device Classification Name	Screw, Fixation, Bone   More FDA Info for this Device
510(K) Number	K012000
Device Name	Screw, Fixation, Bone
Applicant	BIONX IMPLANTS, LTD. P.O. BOX 3 HERMINKATU 6-8L TAMPERE SP-33721 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	HWC Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/27/2001
Decision Date	07/18/2001
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