FDA 510(k) Application Details - K943827

Device Classification Name	Orthosis, Spondyloisthesis Spinal Fixation   More FDA Info for this Device
510(K) Number	K943827
Device Name	Orthosis, Spondyloisthesis Spinal Fixation
Applicant	DANEK MEDICAL, INC. 1800 PYRAMID PL. MEMPHIS, TN 38132 US Other 510(k) Applications for this Company
Contact	RICK TREHARNE Other 510(k) Applications for this Contact
Regulation Number	888.3070   More FDA Info for this Regulation Number
Classification Product Code	MNH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/05/1994
Decision Date	02/14/1996
Decision	SN - Substantially Equivalent for Some Indications
Classification Advisory Committee	OR - Orthopedic
Review Advisory Committee	OR - Orthopedic
Statement / Summary / Purged Status
Type	Traditional
Reviewed By Third Party	N
Expedited Review