FDA 510(k) Application Details - K000797

Device Classification Name	Staple, Fixation, Bone   More FDA Info for this Device
510(K) Number	K000797
Device Name	Staple, Fixation, Bone
Applicant	ORTHOPAEDIC BIOSYSTEMS, LTD. 15990 N GREENWAY-HAYDEN LOOP SUITE 100 SCOTTSDALE, AZ 85260 US Other 510(k) Applications for this Company
Contact	MELODY F MARTIN Other 510(k) Applications for this Contact
Regulation Number	888.3030   More FDA Info for this Regulation Number
Classification Product Code	JDR Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/13/2000
Decision Date	04/03/2000
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