FDA 510(k) Application Details - K101812

Device Classification Name	Intervertebral Fusion Device With Bone Graft, Cervical   More FDA Info for this Device
510(K) Number	K101812
Device Name	Intervertebral Fusion Device With Bone Graft, Cervical
Applicant	ORTHOFIX INC. 1720 BRAY CENTRAL DR. MCKINNEY, TX 75069 US Other 510(k) Applications for this Company
Contact	RUSSELL JOHNSON Other 510(k) Applications for this Contact
Regulation Number	888.3080   More FDA Info for this Regulation Number
Classification Product Code	ODP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/29/2010
Decision Date	09/27/2010
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